- Unique Importer & Distributor Inc
- Issuing Office:
- New York District Office
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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
February 17, 2016
WARNING LETTER NYK-2016-25
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Mohammed Islam, President
Unique Importer & Distributor, Inc.
3520 32nd Street, 1st Floor
Astoria, NY 11106-2756
Dear Mr. Islam:
We inspected your seafood importer establishment, located at 89-21 130th Street, Richmond Hill, NY on December 4-7, 2015. 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). The specific requirements for imported fish and fishery products are set out in 21 CFR Part 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 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 product has been processed under conditions that are 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 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 for 21 CFR Part 123, your frozen Hilsa steak and frozen Hilsa fish from Myanmar is adulterated under section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)] in that is has been prepared, packed, or held under insanitary conditions whereby it 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 violation was as follows:
• You must implement an affirmative step which ensures that the fish and fishery product(s) you import are processed in accordance with the seafood HACCP Regulation, to comply with 21 CFR123.12(a)(2)(ii). However, your firm did not perform an affirmative step for frozen Hilsa steak and frozen Hilsa fish manufactured by May Yu Marine Products Co., Ltd., Yangon, Myanmar.
We note that prior to the conclusion of the December 4-7, 2015 inspection, you submitted a copy of a "Certificate of Registration" dated May 29, 2013 from (b)(4) that certifies that the HACCP (Hazards Analysis and Critical Control Points) plan of May Yu Marine Products Co., Ltd., Yangon, Myanmar for frozen fresh water fish has been assessed and registered according to the provisions of HACCP as an affirmative step. However, this is not adequate to satisfy the requirements of an affirmative step specified by 21 CFR 123 .12. This document does not specify frozen Hilsa steak and frozen Hilsa fish (Tenualosa Ilisha) manufactured by May Yu Marine Products Co., Ltd., Yangon, Myanmar and, therefore, does not provide certification and/or an equivalent level of assurance that the imported fish or fishery products are processed in accordance with seafood Hazard Analysis and Critical Control Point (HACCP) regulations.
On March 19, 2014 FDA collected Sample 853189 of frozen Hilsa, manufactured by May Yu Marine Products Co., Ltd. in Yangon, Myanmar, that was part of an entry offered for import into U.S. commerce. The shipment that this sample was taken from was adulterated within the meaning of section 402(a)(l) of the Federal Food, Drug, and Cosmetic Act (the Act) in that FDA laboratory analysis found Salmonella spp. in the product. The shipment was refused entry on October 7, 2014. In addition, on May 6, 2014, the manufacturer and product were added to Import Alert 16-81, Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella.
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. § 38l(a)], including placing them on "detention without physical examination," seize your product(s) and/or enjoin your firm from further violating the Act.
Additionally, we have comments concerning the entry of your frozen Hilsa, Entry (b)(4):
On October 5, 2015 you offered for entry into U.S. commerce, Entry (b)(4), consisting in part of frozen Hilsa fish and frozen Hilsa steaks. According to the entry documents you supplied at that time, these products were manufactured by (b)(4). These products were allowed entry into U.S. commerce on October 6, 2015 based on the entry documentation you provided to FDA.
During FDA's December 4-7, 2015 inspection at your warehouse, the FDA investigator determined that the manufacturer listed on the product labeling of the frozen Hilsa you entered as part of Entry (b)(4) is May Yu Marine Products Co., Ltd. in Yangon, Myanmar. This manufacturer is subject to Import Alert 16-81, Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella. However, the FDA investigator's review of the entry documents you provided, consisting of Bill of Lading (b)(4) and Invoice (b)(4), revealed that the entry documents do not list May Yu Marine Products Co., Ltd. in Yangon, Myanmar, as the manufacturer of the frozen Hilsa. Because the correct manufacturer information was not provided to FDA when you offered Entry (b)(4) for import, the FDA could not determine at the time that the shipment was subject to Import Alert 16-81. Consequently, no evidence was provided to FDA to ensure that the frozen Hilsa were not contaminated with Salmonella prior to release into United States commerce. As the importer, it is your responsibility to ensure that accurate entry information, including the product manufacturer, is provided to the U.S. Customs broker/entry filer and submitted to FDA so that the Agency may adequately review and evaluate admissibility of the entry.
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 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. You should also describe what actions you will be taken to ensure adequate information is declared in future entries. 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.
Section 743 of the Act [21 U.S.C. § 379j-31] authorizes FDA to assess and collect fees to cover FDA's costs for certain activities, including re-inspection-related costs. Are-inspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA's arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting there-inspection fees [21 U.S.C. § 379j-31(a)(2)(B)]. FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection-related costs.
Please send your written reply to Patricia A. Clark, Compliance Officer, U.S. Food and Drug Administration, 622 Main Street, Suite 100, Buffalo, New York 14202. If you have questions regarding any issues in this letter, please contact Ms. Clark at 716-846-6236 or e-mail at email@example.com.
New York District