Is MIYAQUIL SA Safe? FDA Warning Letter Review (2017)

Detailed Analysis

False Claims and Regulatory Violations

1.    You must have a HACCP plan that, at a minimum, lists the critical limits that must be met, to comply with 21 CFR 123.6 (c) (3). A critical limit is defined in 21 CFR 123.3 (c) as "the maximum or minimum value to which a physical, biological, or chemical parameter must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level the occurrence of the identified food safety hazard." However, the HACCP plan submitted with your January 18th response for your frozen pre-cooked clams lists a critical limit, "(b)(4)" at the Receiving critical control point, that is not adequate, by itself, to control the food safety hazard of Natural Toxins.

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 pre-cooked clams are adulterated, in that they have been prepared, packed, or held under conditions whereby they may have been rendered injurious to health.

Regulatory Context

The U.S. Food and Drug Administration (FDA) inspected your seafood processing facility Miyaquil SA located at Venezuela 4507 Y 16, Guayaquil, Guayas, Ecuador on November 9-10, 2016. During that inspection we found that you had violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21, Code of Federal Regulations, Part 123 (21 CFR 123). At the conclusion of the inspection, the FDA investigator issued an FDA 483, lnspectional Observations, listing the observations made at your firm.

We acknowledge receipt of your response sent via email on January 18, 2017. Your response included a description of your corrective measures, a HACCP plan for frozen pre-cooked clams, sanitation control records and product labels. We have evaluated the documentation and found that you have continuing serious deviations of the seafood HACCP regulation, as further explained in this letter.

You may find the Act, the seafood HACCP regulation and the 4th Edition of the Fish and Fishery Products Hazards and Controls Guidance (the Hazards Guide) through links on FDA's home page atwww.fda.gov. The Hazards Guide, which provides our recommendations regarding identification and control of food safety hazards reasonably likely to occur for your fish and fishery products, can be found on our web site at:http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatorylnformation/Seafood/ucm2018426.htm.