Inspections, Compliance, Enforcement, and Criminal Investigations
Hong's Merchandising Group, Inc. 11/1/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
November 1, 2010
WARNING LETTER NYK-2011-05
Mr. Charlie Hong
Hong's Merchandising Group, Inc.
16-20 Ash Street
Brooklyn, NY 11222
Dear Mr. Hong:
We inspected your seafood processing facility, located at 16-20 Ash Street, Brooklyn, New York on July 30, 2010 and August 2, 2010. 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 refrigerated, aquacultured, vacuum packed yellowtail (aka amberjack or hamachi) fishery 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 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 your refrigerated, aquacultured, vacuum packed yellowtail (aka amberjack or hamachi) fishery products to control the food safety hazard of toxin formation including histamine formation and that of Clostridium botulinum. Please see the Fish and Fisheries Products Hazards & Controls Guidance for additional information on developing critical control points, critical limits, monitoring and corrective action strategies.
We may take further action if you do not promptly correct these violations. For instance, we may take further 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, the seafood HACCP regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (2) 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: Lillian C. Aveta, 158-15 Liberty Avenue, Jamaica, New York 11433. If you have questions regarding any issues in this letter, please contact Lillian Aveta at 718-662-5576.
Ronald M. Pace
New York District
Enclosure: Form FDA 483 dated August 2, 2010