Cermaq Chile S.A. No. 10195 FDA Warning (2017)

Detailed Analysis

False Claims and Regulatory 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 and all applicable regulations, including 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.

Potential Health Risks

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 frozen vacuum-packaged aquacultured salmon 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 FDA's 4th Edition of the Fish and Fisheries Products Hazards & Controls Guidance (the Hazards Guide) through links in FDA's home page atwww.fd

Regulatory Context

On June 5 & 6, 2017, a representative of the U.S. Food and Drug Administration (FDA) conducted an inspection of your seafood processing facility, Cermaq Chile S.A. No. 10195, located at Ruta 5 Sur Kilometro 1105 Ancud, Chiloe, Chile. That inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) Regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123), referred to as seafood HAACP regulation. That inspection resulted in FDA's issuance of an FDA-483, lnspectional Observations, listing the deviations found at your firm at the conclusion of the inspection. FDA did not receive a response from your firm regarding the form FDA-483 to this date.

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 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(a) and (c)(l). 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 HACCP plan for frozen vacuum-packaged aquacultured salmon does not list the food safety hazard ofClostridium botulinumtoxin formation. In addition to ensuring each vacuum-package is labeled with the statement "Keep Frozen, Thaw under Refrigeration immediately

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. More specifically, your response should include documentation and information that would assist us in evaluating your corrections, such as a revised HACCP plan and 5 days of monitoring records. If you cannot complete all corrections within 15 days, you should explain the reason for your delay and state when you will correct any remaining violations.