Inspections, Compliance, Enforcement, and Criminal Investigations
Gold Coast Trading Co. 10/4/12
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|New York District|
158-15 Liberty Avenue
Jamaica, NY 11433
October 4, 2010
WARNING LETTER NYK-2011-1
Daniel Ahenkora, Owner
Gold Coast Trading Co.
381 Canal Place
Bronx, New York 10451-5913
Dear Mr. Ahenkora:
We inspected your seafood processing and importer establishment, located at 381 Canal Place, Bronx, New York between May 7 and May 12, 2010. We collected one sample during this inspection and received the laboratory analyses on May 10, 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 (21 CFR Part 123), and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR Part 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).
As an importer of fish or fishery products, you must operate in accordance with the requirements of 21 CFR 123.12. 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 products have been processed under conditions 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 Act, 21 U.S.C. § 342(a)(4).
Accordingly, your smoked fish is adulterated, in that it 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 (the Hazard Guide) through links in FDA's home page at www.fda.gov.
Your significant violations were as follows:
1. You must have a HACCP plan that, at minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6(c)(3). A critical limit is defined in 21 CFR 123.3(c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, your firm's HACCP plan for "Mudfish, Smoked Mackeral, Akwaabi, Broche, Smoked Tilapia" lists critical limits at the receiving smoked fish and cooler storage critical control points that are not adequate to control Clostridium botulinum or histamine formation.
Furthermore, your HACCP plan fails to address the smoked herring you import, which is not listed on your HACCP Plan Form.
2. 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). However, your firm has not performed a hazard analysis for smoked uneviscerated fish to control the food safety hazard of Clostridium botulinum. With the exception of small uneviscerated fish (under 5 inches in length), FDA considers uneviscerated fish that have been salt-cured, dried, or smoked, as well as products made from them, to be adulterated. A hazard analysis would show that your firm should not receive such uneviscerated fish, which are inherently unsafe whether stored at ambient temperature, refrigerated, or frozen, and whether packaged in air, vacuum, or modified atmosphere.
When conducting your hazard analysis, your firm should assess those steps that are reasonably likely to result in Clostridium botulinum growth and toxin formation, and histamine formation, due to time/temperature abuse. For example, receipt of refrigerated products will likely be critical to ensure that proper temperatures were maintained during the transit period to your facility. In addition, a monthly record review is insufficient; FDA recommends a review of records within one (1) week of the monitoring activity.
In addition, refrigerated finished product storage will likely be critical to ensure proper temperatures are maintained during extended storage periods. FDA recommends the use of equipment capable of monitoring and recording refrigerated temperatures on a 24 hour a day/7 day a week basis, with a daily check of the temperature records and a daily check of the equipment.
For more information related to controlling the hazards of histamine and Clostridium botulinum growth and toxin formation, please refer to Chapters 7 and 13 respectively of the Hazard Guide.
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 HACCP and importer verification records, records that document the performance and results of your firm's affirmative steps, HACCP and verification records associated with your activities as a domestic processor, 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) and the Current Good Manufacturing Practice regulation (21 CFR Part 110). You also have a responsibility to use procedures to prevent further violations of the Act and all applicable regulations for your fish or fishery products, including those that you import into the United States.
Please send your reply to the Food and Drug Administration, Attention: Compliance Officer Dean Rugnetta, 300 Pearl Street, Suite 100, Buffalo, New York 14209.
Ronald M. Pace