FDA WARNING_LETTER - Cermaq Chile S.A. No. 10195 - June 06, 2017

On June 5-6, 2017, the FDA inspected Cermaq Chile S.A.'s seafood processing facility in Ancud, Chile, revealing serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) Regulation (21 CFR Part 123). The firm did not respond to the FDA-483 issued after the inspection.

The primary violation identified was that the firm's HACCP plan for frozen vacuum-packaged aquacultured salmon failed to list Clostridium botulinum toxin formation as a reasonably likely food safety hazard, as required by 21 CFR 123.6(a) and (c)(1). The vacuum-packaged salmon can remain refrigerated for up to 48 hours, increasing the risk. This renders the frozen vacuum-packaged aquacultured salmon adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

The FDA recommends labeling each vacuum-package with "Keep Frozen, Thaw under Refrigeration immediately before use" and implementing controls for Clostridium botulinum toxin formation during refrigerated storage of in-process vacuum-packaged salmon.

The firm must respond in writing within fifteen working days, outlining specific corrective actions, including a revised HACCP plan and five days of monitoring records. Failure to respond adequately may result in refusal of admission for imported products under Section 801(a) of the Act,