Four Star Import & Distribution 12/20/11
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Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||New York District|
Food & Drug Administration
158-15 Liberty Avenue
Jamaica, NY 11433
December 20, 2011
WARNING LETTER NYK-2012-08
VIA UNITED PARCEL SERVICE
Mr. Mohammad Chowdhury
Four Star Import & Distribution, Inc.
1075 Flushing Avenue
Brooklyn, NY 11237
Dear Mr. Chowdhury:
We inspected your seafood importer establishment, located at 1075 Flushing Avenue, Brooklyn, NY 11237 on November 30, 2011 & December 2, 2011.
We found that you have a serious violation of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 C.F.R. Part 123). The specific requirements for imported fish and fishery products are set out in 21 C.F.R. § 123.12. As an importer of fish or fishery products, you must operate in accordance with the requirements of Part 123. In accordance with 21 C.F.R. § 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 C.F.R. Part 123. If assurances do not exist that the imported fish or fishery product has been processed under conditions that are equivalent to those required of domestic processors under 21 C.F.R. Part 123, the fish or fishery products will appear to be adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 342(a)(4) and will be denied entry. Because our inspection identified serious violations of 21 C.F.R. Part 123, your Munia Churi Dry Fish and Noya Boyal Dry Fish are adulterated under Section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4)), 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
We received your response dated December 2, 2011, concerning our investigator’s observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, which was issued to you. We address this response below, in relation to the noted violation. The violation includes, but is not limited to, the following:
1. 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 Munia Churi Dry Fish and Noya Boyal Dry Fish imported by your firm from Bangladesh.
The adequacy of your firm’s response cannot be determined at this time. Your response is simply a promise to correct the violation. No time frame for corrective action was given and no supporting documentation was submitted at the time of the response. It is noted that as of December 20, 2011 no additional documentation was submitted to the United States Food & Drug Administration New York District in response to the violation.
We may take further action if you do not promptly correct this violation. 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.
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 importer verification records and records that document the performance and results of your firm’s affirmative steps, 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). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations for the fish or fishery products that you import into the United States.
Your response should be sent the Food and Drug Administration; Attention:
LCDR Frank Verni
U. S. Food and Drug Administration
158-15 Liberty Avenue, Room 4050
Jamaica, NY 11433
If you have any questions about the content of this letter please contact: LCDR Verni at (718) 662-5702.
Ronald M. Pace
New York District