| Public Health Service Food and Drug Administration |
New York District |
Department of Health and Human Services
September 30, 2011
WARNING LETTER NYK-2011-38
VIA UNITED PARCEL SERVICE
Brian J. Kwon, President
Grand BK Corp.
47-08 Grand Avenue
Maspeth, New York 11378-3007
Dear Mr. Kwon:
We inspected your seafood processing and importer establishment, located at 47-08 Grand Avenue, Maspeth, New York between August 4 and 15, 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 (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 Part 123. 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 salted fish products, including but not limited to, pacific saury, croaker, butterfish, Spanish mackerel, beltfish, atka mackerel, and golden pompano 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 a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6 (c) (3). A critical limit is defined in 21 CFR 123.3 (c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm’s HACCP plan for salted vacuum packed fish lists a critical limit, water phase salt greater than or equal to (b)(4)%, at the brining critical control point that is not adequate to control Clostridium botulinum. We acknowledge that your label states to keep this product frozen, which would control nonproteolytic Clostridium botulinum. However, the product labeling does not include any thawing instructions, which would control the Clostridium botulinum hazard.
2) 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 Salted Fish, which includes salted pacific saury does not list the food safety hazard of scombrotoxin formation.
3) You must take an appropriate corrective action when a deviation from a critical limit occurs, to comply with 21 CFR 123.7(a). However, your firm did not take a corrective action to control
a. Clostridium botulinum when your process for salted croaker, salted butterfish, and salted pacific saury deviated from your critical limit at the brining critical control point. On December 8, 2010, your private lab analysis results for water phase salts for salted croaker (b)(4)(%), salted butterfish (b)(4)(%), and salted pacific saury (b)(4)(%) were below your critical limit for air-packed fish of greater than or equal to (b)(4) % water phase salt. Our inspection reveals you have not taken any corrective action for these products.
b. pathogen growth when your process for salted pacific saury deviated from your critical limit at the packaging / labeling critical control point. Your critical limit for the packaging / labeling critical control point states all products must be labeled (b)(4) During the current inspection, our investigator observed salted pacific saury with out the required labeling statement and you did not take any corrective action.
4) You must implement the record keeping system that you listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(7). However, your firm did not record monitoring observations at the packaging / labeling critical control point to control pathogen growth listed in your HACCP plan for Salted Fish. According to the current inspection this HACCP plan for salted fish includes saury, croaker, Spanish mackerel, beltfish, atka mackerel, and golden pompano that may either be air or vacuum packed.
5) You must monitor sanitation conditions and practices during processing with sufficient frequency to ensure compliance with current good manufacturing practice requirements in 21 CFR Part 110, to comply with 21 CFR 123.11(b). However, your firm did not monitor the safety of water that comes into contact with food or food contact surfaces, and prevention of cross-contamination from insanitary objects with sufficient frequency to ensure compliance with the current good manufacturing practice requirements in 21 CFR Part 110 as evidenced by the following observations made by the FDA investigator on August 4, 2011:
a. a high pressure hose without an appropriate backflow prevention device was observed submerged in tank of raw belt fish;
b. cleaned cutting board were stored on an surface that was not cleaned;
c. food was exposed when the floor was being rinsed with a high pressure hose; and
d. condensate from an air conditioning unit was observed falling onto belt fish prior to processing.
6) You must verify that your HACCP plan is adequate to control food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.8(a). However, your firm did not verify the adequacy of the critical limit of water phase salt greater than or equal to (b)(4)%, for vacuum packed salted fish at the brining critical control point to control Clostridium botulinum. The verification in your HACCP plan of (b)(4) and the verification in your scheduled process of (b)(4) do not require appropriate water phase salt levels to show the identified hazard is controlled. In addition, the frequency of testing is not adequate. Furthermore, your records reveal you are not following this verification procedure. For example, you have water phase salt testing records for February of 2009 and the next record for this testing was eight month later in October 2009, and the next record after this testing was fourteen months later in December of 2010.
7) You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not follow the monitoring procedures of (b)(4) and your scheduled processes for making a brine solution at brining critical control point to control Clostridium botulinum and pathogen growth listed in your HACCP plan for Salted Fish including salted pacific saury.
8) You must implement an affirmative step designed to ensure that the fish and fishery products that you import are processed in accordance with the requirements of seafood HACCP regulations, to comply with 21 CFR 123.12(a)(2)(ii). However, your firm did not perform an affirmative step for saury (a.k.a. mackerel pike/ sanma) imported from (b)(4) located in Japan.
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.
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, records that document the performance and results of your firm’s affirmative steps, HACCP and verification records associated with your activities as a domestic processor, 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 seafood importer establishment operates in compliance with the Act and 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 for your fish or fishery products, including those that you import into the United States.
Your written response should be sent to Dean R. Rugnetta, Compliance Officer, U.S. Food and Drug Administration, 300 Pearl Street, Suite 100, Buffalo, New York 14202. If you have any questions about this letter, please contact Compliance Officer Dean Rugnetta at (716) 541-0324 or Email at dean.rugnetta@fda.hhs.gov.
Sincerely,
/S/
Ronald M. Pace
District Director
New York District
cc: Vinny Kim, Sr. Sanitation Manager, H Mart Inc., 300 Chubb Avenue, Lyndhurst, New Jersey 07071
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