FDA WARNING_LETTER - Yamaya USA Inc. - April 13, 2011

On July 19, 2011, the FDA issued a Warning Letter to Yamaya USA Inc. following an inspection from April 7-13, 2011. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and Current Good Manufacturing Practice (21 CFR Part 110).

The firm's Capelin Roe and Pollack Roe products were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions. Specific violations included:

1. **Inadequate Corrective Actions:** The HACCP plans for frozen Pollack Roe and frozen Capelin Roe had corrective actions at various critical control points (thawing, coloring, seasoning, draining, labeling) that did not ensure the cause of deviations was corrected, violating 21 CFR 123.7(b). 2. **Failure to Implement Affirmative Steps for Imported Products:** The firm did not perform affirmative steps to ensure imported Capelin Roe and Pollack Roe were processed in accordance with seafood HACCP regulations, violating 21 CFR 123.12(a)(2)(ii).

While Yamaya USA Inc. provided a written response on April 21, 2011, outlining proposed corrective actions (amended critical limits, temperature controls