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From: TSS (216-119-144-41.ipset24.wt.net)
Subject: MAD COW WARNING LETTERS USA ''Products that contain protein derived from mammalian tissues'' TEXAS AND GEORGIA
Date: August 10, 2004 at 8:41 am PST

-------- Original Message --------
Subject: MAD COW WARNING LETTERS USA ''Products that contain protein derived from mammalian tissues'' TEXAS AND GEORGIA
Date: Tue, 10 Aug 2004 10:45:53 -0500
From: "Terry S. Singeltary Sr."
To: Bovine Spongiform Encephalopathy
CC: cjdvoice@yahoogroups.com


Public Health Service
Food and Drug Administration

Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3145


June 15, 2004

Ref: 2004-DAL-WL-18

WARNING LETTER

CERTIFIED MAIL
RETURNED RECEIPT REQUESTED

Mr. Patrick ORay, CEO & President
Specialty Brands, Inc.
P.O. Box 51467
Ontario, CA 91761-1057

Dear Mr. ORay:

An inspection of your food manufacturing facility located at 601 E. 3rd
Street, Lampasas, Texas, was conducted on February 26 and March 1, 2004
by Investigators from the Food and Drug Administration (FDA). The
inspection found significant deviations from the requirements set forth
in Title 21, Code of Federal Regulations, Section 589.2000 - Animal
Proteins Prohibited in Ruminant Feed (21 CFR 589.2000). This regulation
is intended to prevent the establishment and amplification of Bovine
Spongiform Encephalopathy (BSE).

Our inspection revealed that your firm sells its reduction stream waste
for use as animal feed and that it contracted with [redacted] to dispose
of this manufacturing process stream waste. [redacted] used this process
stream waste as animal feed for ruminants.

At the close of the inspection, a list of inspectional observations (FDA
483) was issued to your firm and discussed with Mr. Anthony E. Rocz,
Plant Manager. The following violation was observed during the inspection:

Products that contain protein derived from mammalian tissues and that
are intended for use in animal feed must be labeled with the cautionary
statement, Do not feed to cattle or other ruminants, as required by 21
CFR 589.2000(d)(1). For example, your firm manufactures Mexican
specialty food products such as tortillas, taquitos, and burritos that
contain beef. The production process stream waste includes ground corn,
product shells, and filling material, it is then placed in a
transportable bin for disposal by feeding to livestock. This
transportable waste bin did not bear the cautionary statement Do Not
Feed to Cattle or Other Ruminants.

Because your manufacturing stream waste did not bear this cautionary
statement, these products are misbranded within the meaning of section
403(a)(1) of the Federal Food, Drug, and Cosmetic Act.

You should know that this serious violation of the law may result in FDA
taking regulatory action without further notice to you. These actions
include, but are not limited to, seizure and/or injunction.

We are in receipt of a letter from Mr. Anthony E. ROCZ, Plant Manager,
dated March 2, 2004, in which he stated that your factory was under a
contract with [redacted] to remove and dispose of the production stream
waste generated at the factory since April 15, 2003. Our investigators
conveyed to Specialty Brands, Inc., on February 24, 2004, that the
disposal container was not properly labeled to indicate that the
material is not to be fed to cattle or other ruminants in accordance
with the BSE regulation. On February 26, 2004, our investigators
returned to your plant and conveyed to Mr. Rocz that earlier that
morning they observed cattle consuming the manufacturing stream waste
supplied by your firm to [redacted] The practice of supplying process
stream waste to [redacted] was indefinitely suspended on February 26,
2004. At that time, an alternative waste removal service was obtained to
dispose of the process stream waste in a sanitary landfill facility and
each load would be logged, a manifest detailing the pounds of process
waste disposed would be generated, and a certification of proper
disposal is to be provided for the record. This alternative stream waste
disposal process appears to be acceptable. Your letter also states that
your corporate Food Safety and Quality Assurance department is in the
process of drafting a corporate wide policy to ensure that all of your
factories are in compliance with the BSE regulation.

It is necessary for you to take prompt action on this matter now. Please
notify this office in writing within fifteen (15) working days from the
date you receive this letter of the specific actions you have taken to
prevent the recurrence of the violations, and when those actions were
taken or will be taken at your other corporate facilities having similar
disposal plans. Your reply should be sent to Edwin Ramos, Compliance
Officer, at the above stated address. If you have any questions
concerning this letter, you may contact Mr. Ramos at 214-253-5218.

Sincerely,

/s/

Michael A. Chappell
Dallas District Director

cc:
Specialty Brands, Inc.
Mr. Anthony E. Rocz, Plant Manager
601 E Third Street
Lampasas, TX 76550-2903

http://www.fda.gov/foi/warning_letters/g4898d.htm

Public Health Service
Food and Drug Administration

Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3145


June 10, 2004

Ref: 2004-DAL-WL-17

WARNING LETTER

CERTIFIED MAIL
RETURNED RECEIPT REQUESTED

Mr. Jack Chapman, Owner
Chapman Ranch
11071 CR 1255
Lampasas, TX 76550

Dear Mr. Chapman:

An inspection of your ruminant feeding operation located at 11071 CR
1255, Lampasas, Texas, was conducted on February 26 and March 1, 2004 by
Investigators from the Food and Drug Administration (FDA). The
inspection found significant deviations from the requirements set forth
in Title 21, Code of Federal Regulations, Section 589.2000 - Animal
Proteins Prohibited in Ruminant Feed (21 CFR 589.2000). This regulation
is intended to prevent the establishment and amplification of Bovine
Spongiform Encephalopathy (BSE).

Our inspection revealed that you feed prohibited material, as defined by
21 CFR 589.2000(a), to ruminants. This prohibited material consists of
manufacturing process stream waste from [redacted] a manufacturer of
products such as fully cooked tacos, burritos, and taquitos that contain
beef. This manufacturing process stream waste contains meat products
that have been cooked and offered for human food but that have not been
further heat processed for feed. This failure to further heat process
the material causes the feed to be adulterated under section
402(a)(2)(C)(i) because it contains an unapproved food additive (i.e.,
the meat products that have not been further heat processed for feed).

At the close of the inspection, copies of the BSE Guidance documents 69,
70 and 76 were provided to you and further discussed. Also, you
previously received a copy of 21 CFR 589.2000, the BSE regulation, which
was again explained in more specific detail. You should know that this
serious violation of the law may result in FDA taking regulatory action
without further notice to you. These actions include, but are not
limited to, seizure and/or injunction.

It is necessary for you to take action on this matter now. Please send a
written response to this office within fifteen (15) working days from
the date you receive this letter. Your response should specifically
identify the actions you are taking to correct the violations and
provide specific timeframes for achieving compliance. Also, as part of
your written response, you should provide information regarding the
current feeding practices followed at your facility and information
pertaining to the planned marketing of your animals. Your reply should
be sent to Edwin Ramos, Compliance Officer, at the above stated address.
If you have any questions concerning this letter, you may contact Mr.
Ramos at 214-253-5218.

Sincerely,

/s/

Michael A. Chappell
Dallas District Director

horizonal rule

http://www.fda.gov/foi/warning_letters/g4899d.htm


Public Health Service
Food and Drug Administration

Atlanta District Office
60 8th Street, N.E.
Atlanta, Georgia 30309


June 10, 2004

VIA FEDERAL EXPRESS

WARNING LETTER
(04-ATL-13)

M. Dennis Burroughs
President
B & G Seed Company
591 Beck Road
Hull, Georgia 30646

Dear Mr. Burroughs:

An inspection of your feed mill was conducted by a Food and Drug
Administration (FDA) investigator on March 30, 2004. Our investigator
determined that you manufacture various products, including ruminant
feeds, which are animal feeds within the meaning of section 201(w) of
the Federal Food, Drug, and Cosmetic Act (the Act}. The inspection
revealed significant deviations from the requirements set forth in Title
21, Code of Federal Regulations (21 CFR), Part 589.2000
--Animal-Proteins Prohibited in Ruminant Feed. This regulation is
intended to prevent the establishment and amplification of Bovine
Spongiform Encephalopathy (BSE). The deviations cause the feed being
manufactured and distributed by your facility to be misbranded within
the meaning of sections 403(a)(1) of the Act.

The inspection revealed that not all of your feeds that contain protein
derived from mammalian tissues and that are intended for use in animal
feed (prohibited material) were labeled with the statement Do not feed
to cattle or other ruminants, as required by 21 CFR 589.2000(d)(1) and
(c)(1)(i). An example is your B & G Pig Grower. In addition, you have
routinely provided scrap or salvage dog food containing prohibited
material to be used as pig feed that was not labeled with the required
statement. In the case of bulk feed ingredients, the statement could
appear on the placard and invoice that accompany the shipment. The lack
of the required statement causes these feeds to be misbranded as defined
in section 403(a)(1) of the Act.

Our investigator also noted that you had failed to provide for adequate
measures to avoid commingling or cross-contamination of products that
contain or may contain prohibited material into feeds that may be used
for ruminants, as required under 21 CFR 589.2000(e)(1)(iii). You also
failed to establish written procedures for separating products which may
contain prohibited material from all other protein products from the
time of receipt until the time of shipment, as required under 21 CFR
589.2000(e)(1)(iv).

The above is not intended as an all-inclusive list of violations at your
firm. As a manufacturer of animal feeds, you are responsible for
ensuring that your overall operation and the products you manufacture
and distribute are in compliance with the law. We have included a copy
of the FDA Guidance for Industry 68 - Small Entities Compliance Guide -
Protein Blenders, Feed Manufacturers, and Distributors.

You should take prompt action to correct the above violations, and you
should establish procedures whereby such violations do not recur.
Failure to promptly correct these violations may result in regulatory
action without further notice, such as seizure and/or injunction.

You should notify this office, in writing, within fifteen (15) working
days of the receipt of this letter of the steps you have taken to bring
your firm into compliance with the law. Your response should include an
explanation of each step being taken to correct the violations and
prevent their recurrence. We do note that you initiated some corrective
actions during the inspection, including a feed recall and printing new
labels. If corrective action cannot be completed within 15 working days,
state the reason for the delay and date by which the corrections will be
completed. Include copies of any available documentation demonstrating
that corrections have been made. Your response should be directed to
Philip S. Campbell, Compliance Officer, at the address noted in the
letterhead.

Sincerely,

/s/

Mary Woleske, Director
Atlanta District

http://www.fda.gov/foi/warning_letters/g4900d.htm

TSS





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