Inspections, Compliance, Enforcement, and Criminal Investigations
A&A Services 06-Apr-05
Department of Health and Human Services
Public Health Service
San Francisco District
VIA FEDERAL EXPRESS
Our Reference: 3004508183
April 6, 2005
Priscilla D. Shaw
92-353 Laaloa St.
Kapolei, HI 96707
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.
Barbara J. Cas
San Francisco District