Inspections, Compliance, Enforcement, and Criminal Investigations
D & T Foods Co. Inc. 19-Nov-02
San Francisco District
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
VIA FEDERAL EXPRESS
Our Reference: 2954038
November 19, 2002
Mr. Barry Yet, President
D & T Foods Co. Inc.
1261 Martin Avenue
Santa Clara, CA 95050
Dear Mr. Yet:
We inspected your seafood processing facility located at 1261 Martin Avenue, Santa Clara, California on July 31, 2002 and found that you have serious deviations from Title 21, Code of Federal Regulations, Part 123 (21 CFR 123)--Fish and Fishery Products (seafood HACCP regulations). In accordance with 21 CFR 123.6(g), failure of a processor to have and implement a HACCP plan that complies with this section or otherwise operate in accordance with the requirements of this part renders the fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act). Accordingly, your Basa fillets, which are imported from [redacted] frozen shrimp from [redacted] and Dace from [redacted] are adulterated in that the products have been rendered injurious to health. You may find the Act and the seafood HACCP regulations through links in FDA?s home page at www.fda.gov
Your serious HACCP deviations are as follows
1. You must have product specifications that are designed to ensure that the fish and fishery products you import are not adulterated under section 402 of the Act because they may be injurious to health or may have been processed under insanitary conditions, to comply with 21 CFR 123.12(a)(2)(i). However, your firm does not have product specifications for Basa fillets, which are imported from [redacted] frozen shrimp Imported from [redacted] and ?Date? imported from [redacted].
2. You must implement an affirmative step which ensures that the fish and fishery products you import are processed in accordance with the Seafood HACCP regulations to comply with 21 CFR 123.2(a)(2)(ii). However, your firm did not perform an affirmative step for ?Basa? fillets, which are imported from [redacted] frozen shrimp from [redacted] and Dace from [redacted].
We observed the above-mentioned HACCP deviations during previous FDA inspections of your facility in September of 1998 and July of 1999. We discussed your deviations in the untitled letter issued to your firm as a result of the 1998 inspection and by correspondence dated September 23, 1999. A copy of 21 CFR 123, Fish & Fishery Products, is enclosed for your ready reference. We recommend that you review 21 CFR 123.12, Special requirements for imported products.
At the conclusion of the inspection, the seafood deviations were listed on Form FDA 483 (Inspectional Observations) and discussed with you. A copy of this form is enclosed for your ready reference. This list is not meant to be an all-inclusive list of violations It is your responsibility to ensure that all seafood products imported, processed and distributed by your firm are in compliance with the Act and all requirements of the federal regulations.
You should take prompt measures to correct these deviations. Failure to promptly correct the deviations noted may result in regulatory action without further notice. Such action includes seizure and/or injunction. In addition, FDA may detain your imported seafood products without examination when they are offered for import.
Almost three months have elapsed since FDA inspection. Please notify this office in writing within fifteen (15) working days of receipt of this letter of the specific steps you have taken to correct these violations, including an explanation of each step taken to prevent their reoccurrence. You response should include copies of any available documentation demonstrating that corrections have been made. If corrections cannot be completed within 15 working days, state the reason for the delay and the time frame within which the corrections will be completed.
Your response should be directed to: Ms. Harumi Kishida, Compliance Officer, U.S. Food and Drug Administration, 143 1 Harbor Bay Parkway, Alameda, CA 94502-7070.
If you have any questions regarding any issue in this letter, please contact Ms. Kishida at (510) 337-6824
Charles D. Moss for Dennis K. Linsley
San Francisco District