Is Wilbo S.A. Safe? FDA Warning Letter Review (2017)

Detailed Analysis

False Claims and Regulatory Violations

We have reviewed your response received via email on March 20, 2017, in which you state the above-mentioned hazard is identified in your firm's document titled, "Risk analysis and preventive action." Although this document identifies histamine as a food safety hazard, your response is not adequate because you did not provide a new or updated HACCP plan that identifies the hazard of scombrotoxin (histamine) formation and includes appropriate critical control points, critical limits, monitoring procedures, recordkeeping, etc., to control the hazard.

This letter may not list all the violations at your facility. You are responsible for ensuring that your facility operates in compliance with the Act and all applicable regulations, including the LACF regulations (21 CFR 108 and 113), the Seafood HACCP regulation (21 CFR 123), and the current Good Manufacturing Practices 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

As a manufacturer of fish and fishery products, failure to have an implement a HACCP plan that complies with 21 CFR 123.6(g) 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 Act (21 U.S.C. § 342(a)(4)). Accordingly, review of your HACCP plan reveals that your canned seafood products 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 low-acid canned seafood processing facility located at UI. Hutnicza 22, Gdynia, Pomorskie, 81-061 Poland, on March 6-7, 2017. That inspection revealed serious violations of the low-acid canned food regulations (LACF), Title 21, Code of Federal Regulations, Parts 108 and 113 (21 CFR 108 and 21 CFR 113); and violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation, Title 21 Code of Federal Regulations, Part 123 (21 CFR 123). The inspection resulted in FDA's issuance of a FDA-483, lnspectional Observations, listing the deviations found at your firm at the conclusion of the inspection. We acknowledge receipt of your response received via email on March 20, 2017, which included a description of corrections

As a manufacturer of LACF products, you are required to comply with the Food, Drug and Cosmetic Act (the Act) and the federal regulations relating to the processing of LACF products you export to the United States. These regulations are described in 21 CFR 108, Emergency Permit Control, and 21 CFR 113, Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers. As outlined in these regulations, a commercial processor of LACF products that does not adhere to all of the mandatory requirements of 21 CFR 108.35 and 21 CFR 113 could be subjected to an immediate application of the emergency permit control provisions of section 404 of the Act (21 U.S.C. § 344). As stated in 21 CFR 108.35(k), for imported products, in lieu of issuing an order of determination that a permit is re

Your significant LACF violations are as follows: