Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
158 15 Liberty Avenue
Jamaica, NY 11433
December 30, 2015
WARNING LETTER NYK-2016-17
VIA UNITED PARCEL SERVICE
DELIVERY SIGNATURE REQUESTED
Mr. Edward Siaw, Co-Owner
Ms. Dilys Wireko, Co-Owner
Malata African & Caribbean Market
185 McClellan Street #8
Bronx, NY 10456-4810
Dear Mr. Siaw and Ms. Wireko:
We inspected your seafood importer establishment, located at 185 McClellan Street #8, Bronx, NY on October 2, 2015. We found that you have serions 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 smoked herring is adulterated under section402(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 affirmative step for smoked herring manufactured by (b)(4).
On 10/2/2015, FDA collected a sample of smoked herring manufactured by (b)(4) that you offered for import under entry number (b)(4). Your smoked herring, entry number (b)(4) was adulterated within the meaning of section 402(a)(4) of the Act (21 U.S.C. § 342(a)(4)) in that FDA laboratory analysis found the fishery products to be uneviscerated.
The FDA Compliance Policy Guide (CPG) Section 540.650, Uneviscerated Fish Products that are Salt-cured, Dried, or Smoked, provides further guidance. You may access the CPG through links on FDA's home page at www.fda.gov.
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. §38l(a)], including placing them on "detention without physical examination," seize your product(s) and/or enjoin your firm from fmiher 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 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. Are-inspectionis 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 there 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 Compliance Officer Patricia A. Clark at 716-846-
6236 or E-mail at firstname.lastname@example.org.
Ronald M. Pace
New York District