FDA WARNING_LETTER - Polonica Inc. - April 14, 2014

The FDA inspected Polonica Inc.'s seafood processing and import facility in Carteret, NJ, from April 7-14, 2014, finding serious violations of seafood HACCP (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110) regulations.

Key violations include: 1. **Lack of HACCP Plans:** The firm failed to conduct hazard analyses and implement written HACCP plans for marinated herring with dill cream, marinated herring "homestyle," marinated rollmops herring, and vacuum-packed hot smoked mackerel to control hazards like *Clostridium botulinum* toxin, scombrotoxin, and pathogen growth. This violates 21 CFR 123.6(a) and (b). 2. **Inadequate Importer Verification:** The firm lacked product specifications and affirmative steps to ensure imported sprats in oil, sprats in tomato sauce, marinated herring with dill cream, and marinated herring "homestyle" from Poland were processed according to seafood HACCP regulations, violating 21 CFR 123.12(a)(2)(ii).

These violations render the listed products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. The firm's June 2, 2014, response was deemed inadequate.

Polonica Inc. is required to respond within fifteen