DEPARTMENT OF HEALTH & HUMAN SERVICES
April 23, 2012
VIA OVERNIGHT DELIVERY
Ms. Nuez Vilalta Fonfria
Quality Control Manager
Pescados Fabregat S.A.
Camino Viejo Del Mar, 182
Grao de Castellon, Castellon, Spain
Dear Ms. Fonfria:
We inspected your seafood processing facility, Pescados Fabregat S.A., located at Camino Viejo Del Mar, 182, Grao de Castellon, Castellon, Spain on December 19-20, 2011. During that inspection, we found that you had 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.
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 firm’s frozen raw whole octopus appear to be adulterated, in that the products have been prepared, packed, or held under whereby they may have been rendered injurious to health. At the conclusion of the inspection, the FDA investigator issued a FDA-483, Inspectional Observations, listing the deviations found at your firm.
We acknowledge receipt of your response, to the FDA 483, dated December 22, 2011 and additional correspondence on January 5, 2012 that included your HACCP plans, Corrective Action Plan, completed monitoring records, and plant floor plan. Our review of the inspection results, coupled with your responses revealed the following serious deviation from the requirements of the Seafood HACCP regulation:
You must have a HACCP plan that, at a minimum, lists the food safety hazards that are reasonably likely to occur, to comply with 21 CFR 123.6(c)(1). A food safety hazard is defined in 21 CFR 123.3(f) as “any biological, chemical, or physical property that may cause a food to be unsafe for human consumption.” However, your firm’s revised HACCP plans, dated December 2011, for Frozen Raw Octopus – Received Fresh and Frozen Raw Octopus does not list the food safety hazard of Clostridium botulinum.
It was noted during the inspection that your octopus products are packed in plastic bags that are hot sealed. Hot sealing the packages creates an anaerobic environment conducive to Clostridium botulinum growth and potential toxin formation. For frozen products packaged under anaerobic conditions, FDA recommends that firms include a critical control point in their HACCP plans to ensure that proper handling instructions are on each package. These instructions need to state “Keep Frozen” and “Important Keep Frozen, Thaw Under Refrigeration Immediately Before Use
For additional information regarding FDA’s recommended controls for the hazards and controls discussed above, please refer to Chapter 13 of the 4th Edition of the Fish and Fisheries Products Hazards and Controls Guidance: Fourth Edition, which can be found on FDA’s web site at: http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/
You should respond in writing within thirty (30) 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 a copy of any revised HACCP plans, at least five (5) product days worth of monitoring records to demonstrate that you have implemented the revised plan and other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before the 30 days, you should explain the reason for your delay and state when you will correct any remaining violations.
This letter may not list all the deviations at your facility. You are responsible for ensuring that your processing plant operates in compliance with the Act, the Seafood HACCP regulation, and the Good Manufacturing Practice regulation (21 CFR 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 Food and Drug Administration, Attention: Standra Purnell, Compliance Officer, Office of Compliance, Division of Enforcement, Food Adulteration Assessment Branch HFS-607, 5100 Paint Branch Parkway, College Park, MD 20740 U.S.A. If you have any questions regarding this letter, you may contact Standra Purnell via email at firstname.lastname@example.org.
Division of Enforcement
Office of Compliance
Center for Food Safety
and Applied Nutrition