Inspections, Compliance, Enforcement, and Criminal Investigations
Wild Edibles, Inc. 12/4/07
Department of Health and Human Services
|Public Health Service
Food and Drug Administration
New York District
December 4, 2007
RETURN RECEIPT REQUESTED
Wild Edibles, Inc.
21-51 Borden Avenue
Long Island City, NY 11101
Dear Mr. Martin:
We inspected your seafood processing facility, Wild Edibles, Inc. located at 21-51 Borden Avenue, Long Island City, NY 11101 on October 9 and 15, 2007. 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, and the Current Good Manufacturing Practice regulation for foods, Title 21, Code of Federal Regulations, Part 110 (21 CFR 123 & 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). Accordingly, your scombroid-forming species including tuna, mahi-mahi, bluefish and escolar are adulterated, 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.
Your significant violation was as follows:
• You must implement the recordkeeping system that you listed in your HACCP plan for histamine products, to comply with 21 CFR 123 .6(b). However, your firm did not record monitoring observations at the receiving and storage critical control points (CCPs to control histamine formation listed in your HACCP plan for scombroid species).
Specifically, your HACCP plan for histamine-producing species directs the monitoring and recording of temperatures at the receiving and storage critical control points. According to your general manager, this has not been done in years. The controls prescribed in this plan have been applied to your firm's receipt and storage of shellfish, and not the receipt and storage of histamine-producing species, such as tuna, mahi-mahi, bluefish and escolar, processed by your firm.
We may take further action if you do not promptly correct this violation. For instance, we may take further action to seize your product(s) and/or enjoin your firm from operating.
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 this violation. You should include in your response documentation such as HACCP and verification records, 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 processing plant operates in compliance with the Act, 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.
Your reply should be sent to Compliance Branch, Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, NY 11433. Attention: Lillian C. Aveta, Compliance Officer.
Otto D. Vitillo
New York District