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From: TSS ()
Subject: Corpse-carving case accuses 4 of illegally harvesting parts
Date: February 24, 2006 at 9:28 am PST


Feb. 23, 2006, 10:02PM
Corpse-carving case accuses 4 of illegally harvesting parts
Defendants made millions in activity 'out of a cheap horror movie,' the prosecutors say


By TOM HAYS
Associated Press

NEW YORK - The owner of a biomedical supply house was charged along with three other men Thursday with secretly carving up corpses and selling the parts for use in transplants across the country.

The case is "like something out of a cheap horror movie," Brooklyn District Attorney Charles Hynes said.

Prosecutors said the defendants obtained the bodies from funeral parlors in three states and forged death certificates and organ-donor consent forms to make it look as if the parts were legally removed. The defendants made millions of dollars from the scheme, prosecutors said.

The indictment was the first set of charges to come out of a widening scandal involving scores of funeral homes and hundreds of bodies, including that of Masterpiece Theatre host Alistair Cooke, who died in 2004. The investigation has raised fears that some of the body parts could spread disease to transplant recipients.

"I think we can agree that the conduct uncovered in this case is among the most ghastly imaginable," said Rose Gill Hearn, commissioner of the city Department of Investigation. "It was shockingly callous in its disregard for the sanctity of human remains."

Michael Mastromarino, owner of Biomedical Tissue Services of Fort Lee, N.J., was charged along with Brooklyn funeral-home owner Joseph Nicelli.

Mastromarino was an oral surgeon who went into the tissue business after losing his dentist license, prosecutors said. Nicelli was a partner in the business, they said. The other defendants were Lee Crucetta and Christopher Aldorasi.

All four pleaded not guilty to charges of enterprise corruption, body stealing and opening graves, unlawful dissection, forgery and other counts.

A judge in Brooklyn set Mastromarino's bail at $1.5 million and Nicelli's at $250,000. Bail for Crucetta and Aldorasi was $500,000 each.

Prosecutors said the body parts were sold to tissue suppliers and ultimately used in disk replacements, knee operations, dental implants and a variety of other surgical procedures performed by unsuspecting doctors.

The bodies came from funeral homes in New York City, Rochester, N.Y., Philadelphia and New Jersey that contracted with the Brooklyn funeral parlor for embalming.

Prosecutors said more arrests are possible.

Nicelli was paid up to $1,000 per body to deliver corpses to a secret operating room at his funeral parlor, where Mastromarino would remove body parts, authorities said. Crucetta, a nurse, and Aldorasi allegedly helped Mastromarino.
Mastromarino made up to $7,000 a body by selling the tissue. The corpses were then returned to unsuspecting funeral directors. In some cases, Hynes said, bones had been replaced with plastic plumbing pipe.

The scheme began to unravel in late 2004, when a detective responded to a report from the new owner of Nicelli's funeral home that he allegedly cheated customers out of funeral deposits.

The detective grew suspicious when she saw the hidden operating room, NYPD Commissioner Raymond Kelly said.

Mastromarino "vehemently denies doing anything illegal or wrong," defense attorney Mario Gallucci said.

Earlier this month, the Food and Drug Administration closed Biomedical Tissue Services, saying it had evidence the company failed to screen for contaminated tissue.

http://chron.com/disp/story.mpl/nation/3681826.html

> Subject: FDA Orders Biomedical Tissue Services, Ltd., to Cease
Manufacturing
> and to Retain Existing Inventories of ......
> Date: February 5, 2006 at 8:07 am PST
>
> FDA News
>
> FOR IMMEDIATE RELEASE
> P06-17
> February 3, 2006
>
> Media Inquiries:
> Stephen King, 301-827-6242
> Consumer Inquiries:
> 888-INFO-FDA
>
> FDA Orders Biomedical Tissue Services, Ltd., to Cease Manufacturing and to
> Retain Existing Inventories of Human Cells, Tissues and Cellular and
> Tissue-Based Products (HCT/Ps)
>
> Under its comprehensive framework for ensuring the safety of human tissue
> products, the U.S. Food and Drug Administration (FDA) today ordered
> Biomedical Tissue Services, Ltd. (BTS), of Fort Lee, NJ, a human
> tissue-recovery firm, and its CEO and Executive Director of Operations,
> Michael Mastromarino, D.D.S., to immediately cease all manufacturing
> operations. All tissue products initially recovered from human donors by
BTS
> were recalled. FDA is carefully monitoring these recalls to account for
all
> of the tissue distributed.
>
> "FDA's investigation of BTS revealed serious and widespread deficiencies
in
> their manufacturing practices that provide the agency reason to believe
that
> allowing the firm to manufacture would present a danger to public health
by
> increasing the risk of communicable disease transmission," said Margaret
> O'K. Glavin, FDA's Associate Commissioner for Regulatory Affairs.
>
> "FDA's current regulatory framework for Human Tissue and Cellular and
Tissue
> Based Products (HCT/Ps) provides strong measures that the agency can
utilize
> to prevent the introduction, transmission, or spread of communicable
> diseases by HCT/Ps, and require firms to screen and test donors for
relevant
> communicable disease agents and diseases and to ensure that HCT/Ps are
> processed in a way that prevents communicable disease contamination and
> cross-contamination," added Jesse L. Goodman, MD, MPH, director of FDA's
> Center for Biologics Evaluation and Research.
>
> The FDA order to cease manufacturing and to retain HCT/Ps requires BTS to
> suspend any and all manufacturing steps, including but not limited to the
> recovery and shipment of HCT/Ps. FDA's inspection of BTS uncovered serious
> violations of the regulations governing donor screening and record keeping
> practices, as well as failures to follow their own standard operating
> procedures (SOPs), failure to recover HCT/Ps in a manner that does not
cause
> contamination or cross-contamination during recovery, and failure to
> adequately control environmental conditions. Despite records maintaining
> otherwise, the firm had inadequately screened donors for risk factors for,
> or clinical evidence of, relevant communicable disease agents and
diseases.
> In addition, FDA found numerous instances where death certificates
> maintained in BTS' files were at variance with the death certificates FDA
> obtained from the state where the death occurred, on important information
> such as cause, place, and time of death, and the identity of the next of
> kin. After initially focusing efforts on assessing the safety of
distributed
> tissues and facilitating the appropriate recalls, the Agency has
determined
> that these violations, because of their serious nature, constitute a
danger
> to health and is taking this unprecedented action.
>
> FDA continues to investigate BTS' activities and to work cooperatively
with
> tissue processors and appropriate federal, state and local authorities,
and
> will take further actions as needed.
>
> You can view a copy of the BTS Order of Cessation at:
> www.fda.gov/cber/compl/bts013106.htm.
>
> ####
>
> http://www.fda.gov/bbs/topics/news/2006/NEW01309.html
>
> January 31, 2006
>
> CERTIFIED MAIL
> RETURN RECEIPT REQUESTED
>
> Michael Mastromarino, D.D.S.
> CEO & Executive Director of Operations
> Biomedical Tissue Services, Ltd.
> 2125 Center Avenue, Suite 300
> Fort Lee, NJ 07024-5874
>
> Dear Dr. Mastromarino:
>
> The Food and Drug Administration (FDA or the agency) conducted an
inspection
> of your establishment, Biomedical Tissue Services, Ltd. (BTS or
> Establishment), at 2125 Center Avenue, Suite 300, Fort Lee, New Jersey
> 07024, which manufactures human cells, tissues, and cellular and
> tissue-based products (HCT/Ps), between October 4 and 27, 2005. At the
> conclusion of the inspection, the FDA investigators issued you a Form
> FDA-483, Inspectional Observations. In addition to the inspection, the
> agency conducted a concurrent investigation of several funeral homes that
> provided you with potential donors of HCT/Ps for recovery. Our review of
the
> information and records examined and collected during the inspection and
> investigation reveal that significant violations of Title 21, Code of
> Federal Regulations (21 CFR), Part 1271, issued under the authority of
> Section 361 of the Public Health Service Act (PHS Act) [42 U.S.C. 264],
> exist at BTS. The agency has determined that these deviations, because of
> their serious nature, constitute a danger to health. This Order to Cease
> Manufacturing and to Retain HCT/Ps relates exclusively to conduct
occurring
> on or after May 25, 2005, the effective date of these regulations. We note
> that the FDA retains authority to pursue other actions and remedies.
>
> Therefore, pursuant to 21 CFR 1271.440(a)(1) and (3), both you
individually,
> and your Establishment, 1) must immediately cease all manufacturing until
> compliance with the regulations in 21 CFR Part 1271 has been achieved, and
> 2) must retain all HCT/Ps recovered on or after May 25, 2005 that are in
> your possession until they are disposed of as agreed by the agency or
until
> the safety of the HCT/P is confirmed. Pursuant to 21 CFR 1271.3(e),
> "Manufacture" means, but is not limited to, any or all steps in the
> recovery, processing, storage, labeling, packaging, or distribution of any
> HCT/P, and the screening or testing of the HCT/P donor.
>
> Deficiencies noted include, but are not limited to, the following:
>
> 1. You failed to implement the standard operating procedures (SOP or SOPs)
> that you have established for all steps that you perform in determining
> donor eligibility, as required by 21 CFR 1271.47(a), and you failed to
> review the certificate of death for each donor, a relevant medical record,
> regarding risk factors for, or clinical evidence of, relevant communicable
> disease agents and diseases, as required by 21 CFR 1271.75(a). More
> specifically, your standard operating procedure entitled "Donor
> Identification" requires that, when recovering HCT/Ps at a funeral home,
you
> review the death certificate to confirm the eligibility of the donor.
> However, you recovered HCT/Ps from at least eight donors, obtained
from ---
> different funeral homes, located in ------ different states, in which you
> failed to review valid death certificates. The documents purporting to be
> the certificates of death for these donors were collected from BTS during
> our inspection, are not authentic death certificates issued by the state,
> and are inaccurate. For example:
>
> 1. You confirmed the eligibility of donor ------------, who donated HCT/Ps
> at a funeral home in ----------. The donor is listed on the BTS version of
> the certificate of death as being 63 years of age, having died of acute
> myocardial infarction due to coronary artery disease, at ----pm
> on ------------, whereas the State of ---------------issued certificate of
> death lists this donor as being 69 years of age, having died of
multi-organ
> failure, due to liver dysfunction, which in turn was due to thrombosis,
> at ----pm on ------------------;
>
> 2. You confirmed the eligibility of donor --------------, who donated
HCT/Ps
> at a funeral home in ----------------. The donor is listed on the BTS
> version of the certificate of death as being 44 years of age, having died
of
> blunt trauma in a motor vehicle accident, at ----am on ----------------,
> whereas the State of -----------------issued certificate of death lists
this
> donor as being 48 years of age, having died of congestive cardiac failure
> due to atherosclerotic cardiovascular disease, at ----am
> on ------------------;
>
> 3. You confirmed the eligibility of donor -------------, who donated
HCT/Ps
> at a funeral home in ---------------. The donor is listed on the BTS
version
> of the certificate of death as being 70 years of age, having died of
> cardio-pulmonary arrest due to acute myocardial infarction, at ---- pm
> on ------------------, whereas the State of ---------------------issued
> certificate of death lists this donor as being 74 years of age, having
died
> of complications from the intravenous administration of medication due to
a
> radical resection of
> a -----------------------------------------------------------------,
at ----
> pm on ---------------------;
>
> 4. You confirmed the eligibility of donor ------------------, who donated
> HCT/Ps at a funeral home in ---------------. The donor is listed on the
BTS
> version of the certificate of death as having died of cardio-pulmonary
> arrest due to atherosclerotic heart disease, at ----pm
on -----------------,
> whereas the State of -------------issued certificate of death lists this
> donor as having died of cardio-pulmonary asystole due to sepsis and shock,
> at ----pm on --------------;
>
> 5. You confirmed the eligibility of donor ---------------, who donated
> HCT/Ps at a funeral home in ----------------------. The donor is listed on
> the BTS version of the certificate of death as being 45 years of age,
having
> died of blunt trauma due to a motor vehicle accident, at ----pm
> on ---------------, whereas the State of ----------------------issued
> certificate of death lists this donor as being 41 years of age, with a
cause
> of death which was undetermined pending additional studies, at ----pm
> on -------------------;
>
> 6. You confirmed the eligibility of donor -------------, who donated
HCT/Ps
> at a funeral home in -------------. The donor is listed on the BTS version
> of the certificate of death as having died of cardio-pulmonary arrest due
to
> acute myocardial infarction, at ----pm on -----------------, whereas the
> State of ------------------issued certificate of death lists this donor as
> dying of probable ventricular fibrillation due to -------------------
> failure, as a consequence of -------------------- disease, at ----am
> on ----------------------;
>
> 7. You confirmed the eligibility of donor -------------, who donated
HCT/Ps
> at a funeral home in ------------. The donor is listed on the BTS version
of
> the certificate of death as being 58 years of age, having died of acute
> myocardial infarction, at ----am on ----------, whereas the State
> of ---------------------issued certificate of death lists this donor as
> being 50 years of age, having died of diabetes mellitus and hypertension
due
> to cardio-vascular disease, at ----pm on ---------------------------; and
>
> 8. You confirmed the eligibility of donor --------------, who donated
HCT/Ps
> at a funeral home in ----------------. The donor is listed on the BTS
> version of the certificate of death as being 63 years of age, having died
of
> acute myocardial infarction, at ----pm on ------------, whereas the State
> of -------------issued certificate of death lists this donor as being 79
> years of age, having died of pneumonia due to a myocardial infarction,
> at ----pm on -----------------.
>
> 2. You failed to implement the SOPs that you have established for all
steps
> that you perform in determining donor eligibility, regarding your
assessment
> of risk factors for, or clinical evidence of, relevant communicable
disease
> agents and diseases, as required by 21 CFR 1271.47(a). Furthermore, you
> failed to create and maintain accurate records, as required by 21 CFR
> 1271.55(d)(2) and 21 CFR 1271.270(a).
>
> More specifically, your "Documenting the Recovery" SOP requires that, if
the
> donor had been admitted to a health care facility immediately prior to
> death, you were to document the date and reason for admission; check the
> appropriate boxes regarding availability of donor history, physical, and
> discharge summary; check the appropriate box regarding surgeries; check
the
> appropriate boxes regarding availability of lab results (including blood
> cultures, x-rays, and lung biopsies); and check the appropriate boxes
> regarding documentation of HIV, Hepatitis and Tuberculosis infection.
> However, your Medical Evaluation forms for
>
donors -----------------, ---------------, -------------------, ------------
> -, ---------------, and -------------------- (who donated HCT/Ps
> in ---------- different funeral homes located in ---------- different
> states), do not contain any of this information. Instead, you incorrectly
> stated that these donors were "not admitted to a health care facility
> immediately prior to death.," which statements are contradicted by the
> state-issued certificates of death for each of these donors.
>
> 3. You failed to create and maintain accurate records, as required by 21
CFR
> 1271.55(d)(2) and 21 CFR 1271.270(a). More specifically:
>
> 1. The Medical Evaluation forms created and maintained by you for the
> following six donors are inaccurate in that you state that the donors were
> "not admitted to a health care facility immediately prior to death.." In
so
> doing, you also failed to adhere to the following SOPs: Documenting the
> Recovery SOP; Quality Assurance Audit of Donor Records SOP; Quality
> Assurance Check-Off Form; and Audit Check List. These six donors donated
> HCT/P at -----different funeral homes, located in -------- different
states.
> More specifically:
>
> 1. the State of --------------issued certificate of death for
> donor ----------------- states that at the time of her death she was a
> patient at ------------------- Hospital;
> 2. the State of ------------issued certificate of death for
> donor ------------------ states that at the time of his death he was a
> hospital inpatient at ---------;
> 3. the State of --------------issued certificate of death for
> donor ---------- states that at the time of his death he was a patient
> at --------------------- Hospital;
> 4. the State of ----------------issued certificate of death for
> donor ---------- states that at the time of her death she was a patient
> at ------------- Hospital;
> 5. the State of ---------------------issued certificate of death for
> donor ---------- states that at the time of his death he was a patient
> at -------------- Hospital; and
> 6. the State of ---------------issued certificate of death for
> donor --------------- states that at the time of her death she was a
patient
> in the emergency room of ----------------- Hospital.
>
> 2. The records created and maintained by you for donor --------------- are
> inaccurate in that you state in your Certifying Physician Interview form
> that the donor was a 44 year old male who died as a result of a blunt
trauma
> to the head region in a motor vehicle accident; your Circumstances of
Death
> form states that the donor was a 44 year old male who was involved in a
> motor vehicle accident, sustained blunt trauma, and expired at the scene
of
> the accident prior to medical intervention; and your Donor Physical
> Assessment form includes an incorrect schematic of the donor, showing
> fractures to the anterior and posterior portions of the skull, together
with
> bruises or contusions to the anterior and posterior portions of the neck.
> These records are contradicted by the State of --------------------issued
> certificate of death, which states that the donor died of natural causes
> (congestive cardiac failure, resulting from atherosclerotic cardiovascular
> disease), at his home, at the age of 48. The only other significant
> condition which is listed as contributing to the death of the donor in the
> State of --------------issued certificate of death
> is -----------------------. In creating and maintaining these inaccurate
> records, you have also failed to adhere to your "Documenting the Recovery"
> SOP, your "Quality Assurance Audit of Donor Records" SOP, your Audit Check
> List, and your Quality Assurance Check-Off form.
>
> 3. The records created and maintained by you for donor ----------------
are
> inaccurate in that you state in your Certifying Physician Interview form
> that the donor was a 45 year old female who suffered blunt trauma in a
motor
> vehicle accident, and died at the scene of the accident prior to medical
> intervention; your Circumstances of Death form states that the donor was a
> 45 year old female who was involved in a motor vehicle accident, sustained
> blunt trauma to the head region, and expired prior to medical
intervention;
> and your Donor Physical Assessment form includes an incorrect schematic of
> the donor, showing fractures to the anterior and posterior portions of the
> skull, together with bruises or contusions to the anterior and posterior
> portions of the neck. These records are contradicted by the State
> of --------------issued certificate of death, which states that the donor
> died at her home, at the age of 41, was -----, and with an undetermined
> cause of death, pending additional studies. There were no other
significant
> conditions listed as possibly contributing to the death of the donor in
the
> state-issued certificate of death. In creating and maintaining these
> inaccurate records, you have also failed to adhere to your "Documenting
the
> Recovery" SOP, your "Quality Assurance Audit of Donor Records" SOP, your
> Audit Check List, and your Quality Assurance Check-Off form.
>
> 4. The records created and maintained by you for donor ------------- are
> inaccurate and incomplete in that your Certifying Physician Interview form
> for this donor fails to indicate the cause of death; your Circumstances of
> Death form for this donor incorrectly states that the donor was a 70 year
> old female, and fails to indicate the cause of death; your Medical/Social
> History Interview form incorrectly states that the donor never received an
> organ transplant; and your Donor Physical Assessment form for this donor
> fails to show on the schematic that the donor had a surgical procedure to
> her ------------------------ immediately prior to her death, and also
fails
> to show that the donor had undergone a ------ transplant. These records
are
> contradicted by the State of ------------issued certificate of death,
which
> states that the immediate cause of death of this donor was due to
> complications related to the intravenous administration of medication due
to
>
a --------------------------------------------------------------------------
> ----------------------------. The donor is also listed on the State
> of ----------------issued certificate of death as having undergone a
status
> post-cadaver -------- transplant for ------------- disease, and as having
> died at the age of 74. In creating and maintaining these inaccurate
records,
> you have also failed to adhere to your "Quality Assurance Audit of Donor
> Records" SOP, your "Documenting the Recovery" SOP, your Audit Check List,
> and your Quality Assurance Check-Off form.
>
> 5. The records created and maintained by you are inaccurate as concerns
the
> identity of the funeral home from which donors -------, ----------------,
> and ----------------------were obtained and at which HCT/P recovery
> procedures were performed for these donors. In your Donor Demographics
forms
> for these donors you state that their recovery location was a funeral home
> in -----------, -------------, and you also state that the director of the
> funeral home provided you with a positive identification of these three
> donors. However, in an affidavit provided to the agency by the director of
> the funeral home, while he estimates that his funeral homes have provided
> between --- and ---- donors to BTS, they did not provide BTS with these
> three donors. In creating and maintaining these inaccurate records, you
have
> also failed to adhere to your "Quality Assurance Audit of Donor Records"
> SOP, your "Documenting the Recovery" SOP, your Audit Check List, and your
> Quality Assurance Check-Off form.
>
> 4. You failed to implement the SOPs you established for donor eligibility
> determinations specifically for documenting and confirming the identity of
> the donors' next of kin, including your Donor Medical Social History
> Interview SOP, your Quality Control Review of Donor Records SOP, your
> Quality Assurance Audit of Donor Records SOP, your Audit Check List, and
> your Quality Assurance Check-Off form, all as required by 21 CFR
1271.47(a),
> and you failed to create and maintain accurate records, as required by 21
> CFR 1271.55(d)(2) and 21 CFR 1271.270(a), in that you have inaccurately
and
> incompletely recorded the donors' next of kin information. More
> specifically:
>
> 1. The records created and maintained by you for donor ------------ are
> inaccurate and incomplete in that your information on the donor's spouse
> differs from that found in the State of -------------issued certificate of
> death. More specifically:
>
> 1. while your Consent for Donation of Anatomical Gifts form for this donor
> lists the donor's spouse as the consenting next of kin, the donor's spouse
> is incorrectly listed as another individual, residing at an entirely
> different address than the donor;
> 2. while your Medical/Social History Interview form for this donor lists
the
> interviewee as the donor's spouse, the interview form incorrectly
identifies
> the donor's spouse and residential address;
> 3. your Circumstances of Death form for this donor also incorrectly
> identifies the spouse; and
> 4. the BTS version of the certificate of death for this donor is
incomplete
> in that it does not list any surviving spouse, and does not indicate
whether
> the donor was married.
>
> 2. The records created and maintained by you for donor ------------- are
> inaccurate and incomplete in that your information on the donor's spouse
> differs from that found in the State of --------------issued certificate
of
> death. More specifically:
>
> 1. while your Consent for Donation of Anatomical Gifts form for this donor
> lists the donor's spouse as the consenting next of kin, the donor's spouse
> is incorrectly listed as another individual, residing at an entirely
> different address than the donor;
> 2. while your Medical/Social History Interview form for this donor lists
the
> interviewee as the donor's spouse, the interview form incorrectly
identifies
> the donor's spouse and residential address;
> 3. your Circumstances of Death form for this donor also incorrectly
> identifies the spouse; and
> 4. the BTS version of the certificate of death for this donor is
incomplete
> in that it does not list any surviving spouse, and does not indicate
whether
> the donor was married.
>
> 5. You failed to implement the SOPs you established for donor eligibility
> determinations, as required by 21 CFR 1271.47(a), and to assure the timely
> refrigeration of donors and recovery of HCT/P, as required by 1271.180(a).
> You failed to recover HCT/P in a manner that does not cause contamination
or
> cross-contamination during recovery, to adequately control environmental
> conditions, and to provide proper conditions for operations, all as
required
> by 21 CFR 1271.145, 21 CFR 1271.195(a)(1), and 21 CFR 1271.215.
Furthermore,
> you failed to create and maintain accurate records, as required by 21 CFR
> 1271.55(d)(2) and 21 CFR 1271.270(a).
>
> Your SOPs require that donors be refrigerated within ----- hours and that
> HCT/P excision begin within ----- hours post cardiac asystole. However,
you
> did not meet these standards for the following donors:
>
> 1. your Donor Demographics form for donor ------------- states that the
> donor was ".refrigerated within --- hours and tissue excision began
> within ---- hours post cardiac asystole" and that the donor's
refrigeration
> time was at ----am on -----------, which, according to the State
> of --------------------issued certificate of death's time of death (----pm
> on ----------------), is more than 33 hours post-cardiac asystole. Also,
> according to your Tissue Recovery Log form for this donor, HCT/P excision
of
> the donor began at ----pm on --------, almost 48 hours post-cardiac
> asystole. As a result, your Donor Demographics form is inaccurate; and
>
> 2. your Donor Demographics form for donor ---------------states that the
> donor was ".refrigerated within ----hours and tissue excision began
> within ---- hours post cardiac asystole" and that the donor's
refrigeration
> time was at --------------------------------------------, which, according
> to the State
>
of -------------------------------------------------------------------------
> ------------------------issued certificate of death
> (---------------------------------------------), is almost 48 hours
> post-cardiac asystole. Also, according to your Tissue Recovery Log form
for
> this donor, HCT/P excision of the donor began at ----pm on -------------,
> more than 54 hours post-cardiac asystole. As a result, your Donor
> Demographics form is inaccurate.
>
> 6. You failed to implement SOPs you established to assure that HCT/P
> recovery takes place in a suitable environment, as required by 21 CFR
> 1271.180(a). You failed to recover HCT/Ps in a manner that does not cause
> contamination or cross-contamination during recovery, and you failed to
> adequately control environmental conditions and to provide proper
conditions
> for operations, all as required by 21 CFR 1271.145, 21 CFR 1271.195(a)(2),
> and 21 CFR 1271.215. Furthermore, you failed to create and maintain
accurate
> records, as required by 21 CFR 1271.55(d)(2) and 21 CFR 1271.270(a). Your
> SOP requires that the HCT/P recovery site ensure a maintained and
> controlled, closed airflow system so that there is no direct access to the
> outside of the building. However, you recovered HCT/P from
donors ----------
> and ------------ at a funeral home in ------------, ---------- that is not
> equipped with any refrigeration units in which to hold the deceased. The
> embalming room where HCT/P recovery took place was equipped with an
exhaust
> fan that delivered air to the adjacent garage/outside. There was no air
> filtration system in the room. Moreover, you recorded in your Nonstandard
> Tissue Recovery Site Assessment form for these donors that the recovery
site
> ensured a maintained and controlled, closed airflow system so that there
was
> no direct access to the outside of the building.
>
> 7. You failed to implement SOPs you established for donor eligibility
> determinations, specifically to confirm whether an autopsy was performed,
as
> required by 21 CFR 1271.47(a). In particular, your Quality Control Review
of
> Donor Records SOP requires that "[t]he team leader will assure a physical
> exam was performed and the information documented on the recovery
paperwork
> is included in the donor chart." and your Physical Assessment of a
Cadaveric
> Donor SOP requires that the team leader physically check the donor in
their
> entirety. Furthermore, you failed to create and maintain accurate records,
> as required by 21 CFR 1271.55(d)(2) and 21 CFR 1271.270(a). Your Donor
> Demographics forms for donors -------- and ----------------------- state
> that no autopsies had been performed on these donors, and the Donor
Physical
> Assessment forms for these donors provide schematics of the donors which
> fail to show that autopsies had been performed. These documents are
> contradicted by the State of ----------------issued certificates of death
> for these donors, which confirm not only that autopsies were performed on
> these two donors, but also that the autopsy findings were available to
> complete the cause of death. The fact that an autopsy had been performed
> should have been obvious to you upon your physical assessment of the
donors
> at the time of HCT/P recovery.
>
> The above-identified deficiencies are not intended to be an all-inclusive
> list of violations by you and your Establishment. Nevertheless, they
> indicate serious noncompliance with many of the regulations under 21 CFR
> Part 1271, which are designed to protect against the risks of communicable
> disease transmission. Of particular concern are the serious deficiencies
> involving:
>
> 1/ your failure to create and maintain accurate records;
> 2/ your failure to implement SOPs for all steps in determining donor
> eligibility;
> 3/ your failure to recover HCT/Ps in a manner that does not cause
> contamination or cross-contamination during recovery; and
> 4/ your failure to adequately control environmental conditions.
>
> These deficiencies involve donors from numerous funeral homes located in
> different states. Based on the foregoing, the agency finds that there are
> reasonable grounds to believe that HCT/Ps manufactured by you are
violative
> because they were manufactured in contravention of the regulations under
21
> CFR Part 1271 and, therefore, the conditions of manufacture of the HCT/Ps
do
> not provide adequate protections against the risks of communicable disease
> transmission. Moreover, these deficiencies, including your failure to
create
> and maintain accurate records, are so serious and widespread that FDA
finds
> there are reasonable grounds to believe that they present a danger to
public
> health.
>
> This letter confirms the telephone conversation on January 31, 2006, in
> which notice was given that, pursuant to 21 CFR 1271.440(a)(3), you
> individually, and your Establishment, 1) must immediately cease all
> manufacturing, as defined in 21 CFR 1271.3(e), until compliance with the
> regulations in 21 CFR Part 1271 has been achieved, and 2) must retain all
> HCT/Ps recovered on or after May 25, 2005 that are in your possession
until
> they are disposed of as agreed by the agency or until the safety of the
> HCT/P is confirmed. Instructions were given at that time not to recover or
> ship HCT/Ps. Neither you, nor your Establishment, can resume operations
> without prior written authorization from FDA. Any shipment of HCT/Ps in
> violation of this order constitutes a violation of section 368 of the PHS
> Act [42 U.S.C. § 271], for which criminal penalties may be imposed.
>
> Within five (5) working days from the receipt of this Order to Cease
> Manufacturing, you may request a hearing on the matter in accordance with
21
> CFR Part 16 (copy attached), to Mary A. Malarkey, Director, Office of
> Compliance and Biologics Quality, Center for Biologics Evaluation and
> Research, 1401 Rockville Pike, HFM-600, Rockville, MD 20852 (telephone:
> 301-827-6190). Failure to request a hearing within the specified time
period
> constitutes a waiver of the right to a hearing. You may also wish to
inform
> yourself with respect to the agency's guidelines regarding electronic
media
> coverage of its administrative proceedings, which can be found at 21 CFR
> Part 10, Subpart C.
>
> Sincerely,
>
> ----- signature -----
>
> Jesse L. Goodman, M.D., M.P.H.
> Director
> Center for Biologics Evaluation and Research
>
> Effective Date: 31 January Time: 11:25 AM Eastern
>
> Updated February 1, 2006
>
>
> http://www.fda.gov/cber/compl/bts013106.htm
>
>
> TSS


Cadaver corneal transplants -- without family permission
Houston, Texas channel 11 news 28 Nov 99
Reported by Terry S. Singeltary Sr.son of CJD victim


http://www.mad-cow.org/~tom/dec99_news.html#bbb

http://www.rense.com/general62/don.htm

TSS





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