Inspections, Compliance, Enforcement, and Criminal Investigations
LA Fish Company 16-Nov-05
Department of Health and Human Services
Public Health Service
Food and Drug Administration
RETURN RECEIPT REQUESTED
November 16, 2005
Ms. Kimichi Nguyen, Owner
LA Fish Company
116 S. Topo Street
Anaheim, CA 92804-3926
Dear Ms . Nguyen:
The Food & Drug Administration (FDA) concluded an inspection on August 9, 2005 of your seafood importer establishment located at 116 S. Topo Street, Anaheim, CA 92804- 3926. The inspection was conducted to determine your firm's oompliance with FDA's seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21 of the Code of Federal Regulations, Part 123 (21 CFR 123).
During our inspection, the FDA investigator observed serious deviations in your seafood HACCP program, including failure to comply with the importer verification requirements listed in the seafood HACCP regulation, 21 CFR 123.12, "Special Requirements for Imported Products." In accordance with 21 CFR 123 .12(d), failure of an importer of fish or fishery products to operate in accordance with the requirements of Part 123 renders the fish or fishery products adulterated within the meaning of Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4). You can find the Act and its implementing regulations through links on FDA's website, www.fda.gov.
The FDA investigator also provided you with a copy of the FDA 483, Inspectional Observations, which presents an evaluation of your firm's performance regarding various aspects of the HACCP requirements.
The most significant deviations observed were as follows:
l. To comply with 21 CFR 123.12(a)(2), you must have and implement written verification procedures for ensuring that the fish and fishery products you import into the United States were processed in accordance with the requirements of 21 CFR Part 123. Your written verification procedures must list, at a minimum, product specifications that are designed to ensure that the product is not adulterated under section 402 of the Act, and affirmative steps from among the acceptable affirmative steps listed in 21 CFR 123.12(a)(2)(ii) (see 21 CFR 123.12(a)(2)(i) and (ii)). However, your firm did not have and implement an adequate affirmative step for certain products manufactured by one or more foreign processors that you import into the United States. The following deficiencies were noted for particular products and firms:
a. You must have and implement written verification procedures that include, at a minimum, one or more of the affirmative steps listed at 21 CFR 123.12(a)(2)(ii). However, your firm did not have and implement an affirmative step for Frozen Farm Raised Basa Fillets manufactured by [redacted] in [redacted]
b. You must have and implement written verification procedures that include, at a minimum, one or more of the affirmative steps listed at 21 CFR 123.12(a)(2)(ii). Acceptable affirmative steps include obtaining either a continuing or lot-by-lot certificate from an appropriate foreign government inspection authority or competent third party certifying that the imported fish or fishery product is or was processed in accordance with the requirements of 21 CFR Part 123 (see 21 CFR 123.12(a)(2)(ii)(B)). However, your firm submitted a continuing certificate for Frozen Basa, manufactured by [redacted] in [redacted] that was not adequate in that it did not correspond to the name and address of the manufacturer.
The above identified deviations are not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure that you operate in compliance with the Federal Food, Drug, and Cosmetic 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. For instance, we may take further action to refuse admission of your imported seafood products under section 801(a) of the Act, including placing them on "detention without physical examination," seize your product(s), and/or enjoin your firm from further violating the Act.
Please notify this office in writing, within fifteen (15) working days of receipt of this letter of specific steps you have taken to correct these violations, including an explanation of each step taken to prevent their recurrence. Your response should include copies of any available documentation demonstrating that corrections have been made. If corrections cannot be completed within fifteen (15) working days, state the reason for the delay and the time frame within which the corrections will be completed.
If you have questions regarding the implementation of the Seafood HACCP Regulation, you may contact Ruth P. Dixon, Compliance Officer, at (310) 971-2299 for answers and/or direction towards guidance and sources of training in achieving compliance.
Your written reply should be directed to:
U.S. Food & Drug Administration
Attn: J. Lawrence Stevens
Director, Import Operations Branch
Los Angeles District
222 West 6th Street, Suite 700
San Pedro, CA 90731
Alonka E. Cruse