| Public Health Service Food and Drug Administration |
| New York District 158-15 Liberty Avenue Jamaica, NY 11433 |
Department of Health and Human Services
June 24, 2011
WARNING LETTER NYK-2011-25
VIA U.P.S.
Philip Musco, President
Musco Foods Corporation
57-01 49th Place
Maspeth, NY 11378
Dear Mr. Musco:
We inspected your seafood processing and importer establishment, located at 57-01 49th Place, Maspeth, NY 11378, on March 25, 2011 through April 11, 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 refrigerated cooked ready-to-eat marinated anchovies in sunflower oil, refrigerated cooked ready-to-eat seafood salad in sunflower oil and refrigerated cooked ready-to-eat octopus salad in sunflower oil 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 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 refrigerated cooked ready-to-eat marinated anchovies in sunflower oil to control the food safety hazards of histamine and pathogen growth, including Clostridium botulinum growth and toxin formation; or for refrigerated cooked ready-to-eat seafood salad in sunflower oil and octopus salad in sunflower oil to control the food safety hazards of pathogen growth, including Clostridium botulinum growth and toxin formation.
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). However, your firm did not perform an affirmative step for refrigerated cooked ready-to-eat marinated anchovies in sunflower oil and refrigerated cooked ready-to-eat octopus salad in sunflower oil imported from (b)(4) or for refrigerated cooked ready-to-eat seafood salad in sunflower oil imported from (b)(4)
We received the electronic message (attached) dated May 6, 2011 from your import broker, (b)(4) responding to the form FDA483.
With respect to the term “processing” discussed in this electronic message, this term is defined in 21 CFR § 123.3 (k)(1) as follows: “Processing means, with respect to fish or fishery products: Handling, storing, preparing, heading, eviscerating, shucking, freezing, changing into different market forms, manufacturing, preserving, packing, labeling, dockside unloading, or holding.” In view of this definition, Musco Food Corp. meets the definition of a “processor.”
With respect to your foreign suppliers for the products covered during our inspection, these firms are not covered by a seafood HACCP MOU. As such, this response does not adequately address the observations noted in the form FDA-483.
We may take further action if you do not promptly correct these violations. For instance, we may take action to seize your product(s) and/or enjoin your firm from operating.
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 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.
Please send your reply to the Food and Drug Administration, Attention: Lillian C. Aveta, 158-15 Liberty Avenue, Jamaica, NY 11433. If you have questions regarding any issues in this letter, please contact Ms. Aveta at 718-662-5576.
Sincerely,
/S/
Ronald M. Pace
District Director
New York District
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