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From: TSS ()
Subject: MAD COW WARNING LETTER RUMINANT FEED April 6, 2005 FDA
Date: April 22, 2005 at 9:35 am PST

-------- Original Message --------
Subject: MAD COW WARNING LETTER RUMINANT FEED April 6, 2005
Date: Fri, 22 Apr 2005 11:45:20 -0500
From: "Terry S. Singeltary Sr."
To: Bovine Spongiform Encephalopathy


Department of Health and Human Services

Public Health Service
Food and Drug Administration

San Francisco District
1431 Harbor Bay Parkway
Alameda. CA 94502-7070
Telephone : 510-337-6700


VIA FEDERAL EXPRESS

Our Reference: 3004508183

April 6, 2005

Priscilla D. Shaw
Owner
A&A Services
92-353 Laaloa St.
Kapolei, HI 96707

WARNING LETTER

Dear Ms. Shaw:

On January 10 and 11, 2005, we inspected your animal feed distribution
operation located at 92-353 Laaloa St., Kapolei, HI 96707, and found
significant deviations from the requirements set forth in Title 21, Code
of Federal Regulations, Section 589.2000 (21 C.F.R. 589.2000)-Animal
Proteins Prohibited in Ruminant Feed. The regulation is intended to
prevent the establishment and amplification of Bovine Spongiform
Encephalopathy (BSE).

Products that contain or may contain protein derived from mammalian
tissues and that are intended for use in animal feed (prohibited
material) must be labeled with the cautionary statement, "Do not feed to
cattle or other ruminants" [21 C.F.R. 589.2000(d)(1) and (cx1)(i)]. Our
inspection found that you are not labeling the products you are
distributing to swine farms, which contain food waste from restaurants
and hospital cafeterias, with this caution statement. As a result, these
products are misbranded within the meaning of Section 403(a)(1) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(a)(1)).

Our inspection also found that you use the same containers to hold both
prohibited materials [redacted] waste to be used for feed for
non-ruminants and non-prohibited materials [redacted] waste to be used
for feed for ruminants). However, you failed to provide written
procedures specifying clean-out procedures or other measures to avoid
cross-contamination of the feed products to be used for ruminants [21
C.F.R. 589.2000(e)(1)(iv)]. You also failed to make copies of
distribution records available for FDA inspection and copying (21 C.F.R.
589.2000(c)(1)(ii)].

At the conclusion of the inspection, these and other observations were
listed on Form FDA 483, Inspectional Observations, which was issued to
and discussed with you at the close of the inspection . A copy of this
form is enclosed for your ready reference.

The above is not meant to be an a11-inclusive list of deficiencies at
your facility. It is your responsibility to ensure that all of your
products are in compliance with the law. You should take prompt action
to correct these violations, and you should establish a system 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 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. If corrective actions cannot be completed in
fifteen (15) days, state the mason for the delay and the date by which
the corrections will be completed. Include copies of any available
documentation demonstrating that corrections have been made.

Your reply should be directed to Paul A. Peterson, Compliance Officer,
Food and Drug Administration, 1431 Harbor Bay Parkway, Alameda, CA
94502. If you have any questions regarding any issue in this letter, you
may contact Mr. Peterson at (510) 337-6856.

Sincerely,

/S/

Barbara J. Cas
District Director
San Francisco District

http://www.fda.gov/foi/warning_letters/g5272d.htm

TSS





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