Inspections, Compliance, Enforcement, and Criminal Investigations
Trans-Pacific Assets Management Inc. 9/5/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|San Francisco District|
1431 Harbor Bay Parkway
Alameda, CA 94502-7070
VIA UNITED PARCEL SERVICE
September 5, 2012
Mr. Anthony Y. Ang
Trans-Pacific Assets Management
2345 Industrial Pkwy West
Hayward, California 94545
Dear Mr. Ang:
The Food and Drug Administration (FDA) conducted an inspection of your facility located at 2345 Industrial Pkwy West, Hayward, California on July 23-August 3, 2012. We found that you have a serious violation of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123). The specific requirements for imported fish and fishery products are set out in 21 CFR 123.12. As an importer of fish or fishery products, you must operate in accordance with the requirements of Part 123. In accordance with 21 CFR 123.12(d), there must be evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that comply with 21 CFR Part 123. If assurances do not exist that the imported fish or fishery product has been processed under conditions that are equivalent to those required of domestic processors under 21 CFR Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4), and will be denied entry. Because our inspection identified serious violations for 21 CFR Part 123, your (b)(4) Sardines in Tomato Sauce, (b)(4) Mackerel in Natural Oil, and (b)(4) Dried Herring with Garlic in Olive Oil imported from the Phillipines are adulterated under Section 402(a)(4) of the Act, 21 U.S.C. § 342(a)(4), in that they have been prepared, packed, or held under insanitary conditions whereby they may have been rendered injurious to health. You may find the Act, the seafood HACCP regulation and the Fish and Fisheries Products Hazards & Controls Guidance through links in FDA's home page at www.fda.gov.
Your significant violations are as follows:
- You must have product specifications that are designed to ensure that the fish and fishery products that you import are not injurious to health, to comply with 21 CFR 123.12(a)(2)(i). However, your firm imports (b)(4) Sardines in Tomato Sauce and (b)(4) Mackerel in Natural Oil and you do not have product specifications to address the hazards of histamine, undeclared food allergens, or potential metal and glass inclusion. Additionally, your firm imports (b)(4) Dried Herring with Garlic in Olive Oil and you do not have product specifications to address the hazards of histamine, undeclared food allergens, potential metal and glass inclusion, or potential Staphylococcus aureus toxin formation.
- You must implement an affirmative step designed to ensure that the fish and fishery products that you import into the United States were processed in accordance with the requirements of FDA's seafood HACCP regulations, to comply with 21 CFR 123.12(a)(2)(ii). However, your firm did not implement an affirmative step for the importation of the following products;
- (b)(4) Sardines in Tomato Sauce imported from (b)(4), Phillipines.
- (b)(4) Mackerel in Natural Oil imported from (b)(4), Phillipines.
- (b)(4) Dried Herring with Garlic in Olive Oil imported from (b)(4), Phillipines.
For additional information and guidance, please refer to the Fish and Fisheries Products Hazards and Controls Guidance: 4th Edition (the Hazard Guide) through links in FDA's home page at www.fda.gov.
We may take further action if you do not promptly correct this violation. For instance, we may take further action to refuse admission of your imported fish or fishery products under Section 801(a) of the Act, 21 U.S.C. § 381(a), including placing them on "detention without physical examination," seize your product(s) and/or enjoin your firm from further violating the Act.
You should respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to correct these violations. You should include in your response documentation, such as HACCP and importer verification records and records that document the performance and results of your firm’s affirmative steps, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Section 743 of the Act (21 U.S.C. 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including re-inspection-related costs. A re-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees (21 U.S.C. 379j-31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
This letter may not list all the violations at your facility. You are responsible for ensuring that your seafood importer establishment operates in compliance with the Act and the seafood HACCP regulation (21 CFR Part 123). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations for the fish or fishery products that you import into the United States.
Your written response should be directed to:
Lawton W. Lum
Director of Compliance
1431 Harbor Bay Parkway
Alameda, California 94502
Refer to the Unique Identification Number (CMS 352700) when replying.
If you have any questions about the content of this letter please contact Ms. Aleta T. Flores, Compliance Officer at (510) 337-6821.
Barbara J. Cassens