Hong Kong Food Co. 10/11/11
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Los Angeles District|
Irvine, California 92612-2506
Telephone (949) 608-2900
Fax (949) 608-4415
RETURN RECEIPT REQUESTED
October 11, 2011 W/L 02-12
Peter (nmi) Taing, President
Hong Kong Food Co.
2307 East Olympic Boulevard
Los Angeles, CA 90021-2507
Dear Mr. Taing:
We inspected your seafood processing facility, Hong Kong Food Company located at 2307 East Olympic Blvd., Los Angeles, California between August 16 and September 1, 2011. 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, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 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). Accordingly, your vacuum-packaged fish ball, shrimp ball, “cuttlefish” ball and fish paste products are adulterated, 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 were as follows:
1. You must have Critical Control Points that are necessary to control each food safety hazard reasonably likely to occur in your products, to comply with 21 CFR 123.6(c)(2). However, your HACCP plan for Fresh and Frozen Fish Balls does not have a critical control point to control (“CCP”) for the food safety hazard of growth and toxin production of Clostridium botulinum type E and nonproteolytic types B and F for the refrigerated products covered under this plan.
2. Your HACCP plan must list monitoring procedures that ensure compliance with the critical limit, to comply with 21 CFR 123.6(c)(4). However, your HACCP plan for Fresh and Frozen fish Balls lists a monitoring frequency at CCP #4 (Storage) that is not sufficient for the control of Clostridium botulinum growth and toxin formation in the refrigerated, vacuum-packaged fishery products that are stored refrigerated. Your plan states that a visual temperature check will be made during operational periods of (b)(4). This monitoring frequency does not ensure that these products are held at appropriate temperatures during overnight and extended non-operational periods.
3. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(a) and (c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as “any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.” However, your firm’s HACCP plan for Fresh and Frozen Fish Balls does not list the following food safety hazards:
- Undeclared allergens and food intolerance causing substances. These products pose a hazard for allergens and food intolerance causing substances based on the presence of the fish proteins and shrimp. Please refer to Chapter 19 of the Hazard Guide for additional information related to the hazard of undeclared allergenic and food intolerance causing substances;
- Metal inclusion: Please refer to Chapter 20 of the Hazard Guide for information related to control of metal fragments in fishery products.
4. You must conduct or have conducted for you a hazard analysis for each kind of fish and fishery product that you produce to determine whether there are food safety hazards that are reasonably likely to occur and you must have and implement a written HACCP plan to control any food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6 (a), and (b). However, your firm does not have a HACCP plan for fish paste and fish cakes packaged in plastic tubs, to control the food safety hazards of undeclared food allergens and metal fragments.
Please note that the 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance (the Hazard Guide) may be found on our web site at:
The above violations are not meant to be an all-inclusive list of deficiencies in your plant. 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. We may take further action if you do not promptly correct these violations. Failure to do so may result in regulatory action without further notice, including but not limited to, seizure and/or injunction.
Please 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, labeling, 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.
Your response should be sent to:
Mr. Blake Bevill
Director, Compliance Branch
Food and Drug Administration
Irvine, CA 92612-2506
If you have any questions about the content of this letter please contact Mr. Robert McNab, Compliance Officer at 949-608-4409.
Alonza E. Cruse