Inspections, Compliance, Enforcement, and Criminal Investigations
East Coast Meat & Seafood 25-Sep-07
Department of Health and Human Services
Public Health Service
555 Winderley Pl., Ste. 200
RETURN RECEIPT REQUESTED
September 26, 2007
Cindy Vega, President
East Coast Meat & Seafood
1133 53rd Court North
West Palm Beach, Florida 33407
Dear Ms. Vega:
We inspected your seafood processing facility, located at the above address on June 25 and 26, 2007, and July 2, 2007. 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, 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 raw, fresh, refrigerated scombroid species of fish 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 violations were as follows:
1. You must implement the monitoring procedures and frequency that you have listed in your HACCP plan, to comply with 21 CFR 123.6(b) and (c)(4). However, your firm did not follow the monitoring procedures of:
a. Examining "bills of lading from all incoming product shipments. . . to verify harvesting area" at the critical control point of receiving to control the hazard of histamine toxin formation as listed in your HACCP plan for raw, fresh, refrigerated scombroid fish.
b. Examining on a routine basis "all fresh product lots. . . for adequate icing" and "decomposition and quality loss by means of physical and sensory testing" at the critical control point of receiving to control the hazard of histamine toxin formation as listed in your HACCP plan for raw, fresh, refrigerated scombroid fish.
2. You must conduct a hazard analysis to determine whether there are food safety hazards that are reasonably likely to occur and have a HACCP plan that, at a minimum, lists the critical control points, to comply with 21 CFR 123.6(a) and (c)(2). A critical control point is defined in 21 CFR 123.3(b) as a "point, step, or procedure in a food process at which control can be applied, and a food safety hazard can as a result be prevented, eliminated, or reduced to acceptable levels." However, your firm's HACCP plan for raw, fresh, refrigerated scombroid fish does not list the critical control point of storage for controlling the food safety hazard of histamine formation.
3. You must fully document in your records all corrective actions taken,''to comply with 21 CFR 123.7(d). However, you did not document that corrective actions were taken in 2006 and 2007 when you deviated from your critical limits of product temperature exceeding 45°F and/or signs of decomposition for raw, fresh, refrigerated scombroid fish at the critical control point of receiving, to control the hazard of histamine formation.
We may take further action if you do not promptly correct these violations. For instance, we may take further action to seize your product 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.
Please send your reply to the Food and Drug Administration, Attention: Matthew B. Thomaston, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, FL 32751. If you have questions regarding any issues in this letter, please contact Mr. Thomaston at (407) 475-4728.
Emma R. Singleton
Director, Florida District