Inspections, Compliance, Enforcement, and Criminal Investigations
Pacific American Fish Co., Inc 10/16/09
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
|New England District
One Montvale Avenue
Stoneham, Massachusetts 02180
FAX: (781) 596-7896
October 16, 2009
VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Mr. Paul Huh, CEO
Pacific American Fish Co., Inc.
5525 South Santa Fe Avenue
Vernon, CA 90058
Dear Mr. Huh:
We inspected your seafood processing facility and importer establishment located on 18 FID Kennedy Avenue, Unit 7, Boston, MA 02210-2365, on 7-2-09, 7-8/10-09, and 7-14-09. We found that you have serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR Part 123), and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 110). In accordance with 21 CFR 123.6(g), failure of a processor of fish or fishery products to have and implement a HACCP plan that complies with this section or otherwise 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).
As an importer of fish or fishery products, you must operate in accordance with the requirements of 21 CFR 123.12. 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 Part123. If assurances do not exist that the imported fish or fishery products have been processed under conditions 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 Act, 21 U.S.C. §342(a)(4).
Accordingly, your fresh tuna is adulterated, in that it has been prepared, packed, or held under insanitary conditions whereby it 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 were as follows:
As a Domestic Processor:
1) You must have a HACCP plan that, at a minimum, lists monitoring procedures for each critical control point, to comply with 21 CFR 123.6 (c)(4). However, your firm’s HACCP plan for fresh tuna lists a monitoring frequency at the ”Chilled Storage” critical control point that is not adequate to control the hazard of histamine formation. Specifically, visually monitoring the cooler thermometer twice daily provides no information about the storage temperatures between these checks. FDA recommends the use of monitoring equipment that is capable of monitoring and recording cooler temperatures on a continuous basis.
2) Because you chose to include a corrective action plan in your HACCP plan, your described corrective action must be appropriate, to comply with 21 CFR 123.7(b). However your corrective action plan for fresh tuna at the refrigerated storage critical control point to control histamines is not appropriate. Specifically, your HACCP plan lists that you will “re-ice fish”. However, re-icing fish that has already been temperature abused is not appropriate because it will not prevent the distribution of potentially adulterated product.
As an Importer:
1) You must have product specifications that are designed to ensure that the fish and fishery products you import are not injurious to health, to comply with 21 CFR 123.12 (a)(2)(i). However, your firm does not have a product specification for your fresh tuna, specifically to address the histamine hazard.
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 regulation, to comply with 21 CFR 123. 12 (a)(2)(ii). This affirmative step must provide adequate evidence that all fish and fishery products offered for entry into the United States have been processed under conditions that are equivalent to those required of domestic processors, to comply with 21CFR 123.12(d). However, your affirmative step which is maintaining on file a copy of the foreign processor's HACCP plan for your fresh tuna, in accordance with 21 CFR 123.12(a)(2)(ii)(D) is not adequate because you are not maintaining a written letter of guarantee from the foreign processor to verify that the products were processed in accordance with requirements of the seafood HACCP regulation.
We may take further action if you do not promptly correct these violations. 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.
We are in receipt of your letter of August 7, 2009 responding to the List of Inspectional Observations, FDA Form 483, issued on August 14, 2009 at the conclusion of the inspection. The corrective actions which you propose do not adequately address the following concerns raised by the FDA 483, in that:
• You provided no documentation on the type of instrumentation installed or data generated by the instrument to show it was installed and working properly.
• You did not include an updated/amended HACCP plan detailing critical limits, monitoring frequency and inclusion of a corrective action at the "Chilled Storage" critical control point.
• You did not provide us with your written specifications for imported fresh tuna.
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 verification records, 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.
This letter may not list all the violations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations.
Please send your reply to the Food and Drug Administration, Attention: Attention: Lori A. Holmquist, Compliance Officer, 330 Civic Center Drive, Suite 1, Box 4, Augusta, Maine 04330. If you have questions regarding any issues in this letter, please contact Ms. Holmquist at
207.622.8268 x 13.
John R. Marzilli
New England District
cc: Mr. Dale Silva, Manager
8 FlO Kennedy Avenue, Unit 7
Boston, MA 02210-2365