Inspections, Compliance, Enforcement, and Criminal Investigations

Lucky Pacific Corp and Kamli International Co. Ltd. 3/2/17

 

  

Black HHS-Blue FDA Logo

 

 

 
New York District
158-15 Liberty Ave
Jamaica, NY 11433 

 

March 2, 2017
 
WARNING LETTER NYK-2017-5
 
 
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
 
Mr. Kam Yam Lam, Owner
Lucky Pacific Corp. and Kamli International Co. Ltd.
47-57 Bridgewater Street
Brooklyn, NY 11222
 
 
Dear Mr. Lam:.
 
On October 24, 2016 and November 9, 2016 the U.S. Food and Drug Administration (FDA) inspected your seafood importer establishments Lucky Pacific Corp. and Kamli International Co. Ltd., both located at 47-57 Bridgewater Street, Brooklyn, NY 11222. 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 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 ready-to-eat dried fish snacks and ready-to-eat dried fish skin snacks 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 theymay 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 your imported seafood products as follows:
    • Ready-to-eat dried fish snack imported by your firm Lucky Pacific Corp. manufactured by (b)(4) located in (b)(4)
    • Ready-to-eat dried fish skin snack imported by your firm Kamli International Co. Ltd. manufactured by (b)(4) located in (b)(4)
    • Ready-to-eat dried fish snack imported by your firm Kamli International Co. Ltd. manufactured by (b)(4) located in (b)(4).
We acknowledge your undated Kamli International Co. Ltd. and Lucky Pacific Corp. firm responses include product specifications and importer verification procedures for the above stated products. Your Kamli International Co. Ltd. response also includes a test report issued by “(b)(4)”.  However, it is not clear what product(s) this report is associated with and the report is not adequate to satisfy the requirements of an affirmative step specified by 21 CFR 123.12. The report 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.
 
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 corrected 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.
 
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. A re-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 the re-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.
 
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.
 
Please send your reply to the Food and Drug Administration, One Winners Circle, Suite 110, Albany, NY 12205, Attention: CDR Catherine Beer. If you have questions regarding any issues in this letter, please contact CDR Catherine Beer at (518) 453-2314 x1015.
 
 
Sincerely,
/S/ 
Ronald M. Pace
District Director
New York District

Page Last Updated: 03/06/2017
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