FDA WARNING_LETTER - Wilbo S.A. - March 07, 2017

On August 8, 2017, the FDA issued a Warning Letter to Wilbo S.A. following a March 6-7, 2017 inspection of their low-acid canned seafood processing facility in Gdynia, Poland. The inspection revealed serious violations of low-acid canned food (LACF) regulations (21 CFR 108 and 113) and seafood Hazard Analysis and Critical Control Point (HACCP) regulations (21 CFR 123).

Key LACF violations included: 1. Failure to process low-acid canned food in conformity with the scheduled process, specifically regarding minimum processing temperature, time, and maximum fill weight for Salmon and Tuna Salad in Tomato Sauce with Vegetables. 2. Failure to obtain substantiation by a qualified scientific authority for intentional changes to previously filed scheduled processes. 3. Failure to file evidence of adequate heat distribution for retort installation, with the most recent studies from 2006/2007 despite retort reconfiguration. 4. Failure to determine and record initial product temperature with sufficient frequency and at the correct point in the process. 5. Improper placement of the temperature recorder sensor, leading to inaccurate temperature measurements.

A significant seafood HACCP violation was the firm's HACCP plan for canned seafood products failing to list scombrotoxin (histamine) formation associated with mackerel, herring, and sprat, and