CC: cjdvoice@yahoogroups.comPublic Health Service
Food and Drug Administration
New Orleans District
Southeast Region
6600 Plaza Drive, Suite 400
New Orleans, Louisiana 70127
Telephone: 504-253-4519
Facsimile: 504-253-4520
December 9, 2004
WARNING LETTER NO. 2005-NOL-07
FEDERAL EXPRESS
OVERNIGHT DELIVERY
Mr. Alan O. Bostick, President
Sunshine Mills, Inc.
500 6th Street SW
Red Bay, Alabama 35582
Dear Mr. Bostick:
On September 7 and 14, 2004, a United States Food and Drug
Administration (FDA) investigator inspected your animal feed
manufacturing facility, located at 2103 South Gloster Street, Tupelo,
Mississippi. The inspection revealed significant deviations from the
requirements set forth in Title 21, Code of Federal Regulations, Part
589.2000 (21 CFR 589.2000) - Animal Proteins Prohibited in Ruminant
Feed. The regulation is intended to prevent the establishment and
amplification of Bovine Spongiform Encephalopathy (BSE). Because you
failed to follow the requirements of this regulation, products you
manufactured and/or distributed are misbranded within the meaning of
Section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act).
The inspection indicated you manufacture products containing beef meat
and bone meal. Products that contain or may contain protein derived from
mammalian tissues, as defined by 21 CFR 589.2000(a), and are intended
for use in animal feed, must be labeled with the cautionary statement
Do not feed to cattle or other ruminants. This is required by 21 CFR
589.2000(c)(1)(i). Your firm failed to label your non-ruminant products
with this required cautionary statement. Specifically, the products that
contained protein derived from mammalian tissues but lacked the required
statement included your Happy Fisherman and Premier catfish feeds.
Under 21 CFR 589.2000(g)(2), failure of these feeds to bear the required
cautionary statement causes them to be misbranded under Section
403(a)(1) of the Act.
The above is not intended to be an all-inclusive list of deviations from
regulations. As a manufacturer of materials intended for animal feed
use, you are responsible for assuring your overall operation and
products you manufacture and distribute are in compliance with the law.
A copy of FDAs Small Entity Compliance Guide is enclosed to assist you
in complying with the regulations.
You should take prompt action to correct these violations and establish
a system whereby such violations do not recur. Failure to promptly
correct these violations may result in regulatory action, such as
seizure and/or injunction, without further notice.
We are aware you sent label corrections for the last shipment of each of
the mislabeled products. You also stated you plan [redacted] However,
you should notify this office in writing, within 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 taken to correct violations and prevent their
recurrence. If corrective action cannot be completed within 15 working
days, state the reason for delay and date by which corrections will be
completed. Include copies of any available documentation demonstrating
corrections have been made.
Please send your reply to the U.S. Food and Drug Administration,
Attention: Nicole F. Hardin, Compliance Officer, at the above address.
If you have questions regarding any issue in this letter, please contact
Ms. Hardin at (504) 253-4519.
Sincerely,
/s
H. Tyler Thornburg
District Director
New Orleans District
Enclosures:
FDA Form 483
FDAs Small Entity Compliance Guide
21 CFR 589.2000
cc:
[redacted]
General Manager
Sunshine Mills, Inc.
2103 South Gloster Street
Tupelo, Mississippi 38801
http://www.fda.gov/foi/warning_letters/g5105d.htm
TSS
