FDA WARNING_LETTER - Royal Foods - September 20, 2013

On September 19-20, 2013, the FDA inspected Royal Foods Co. Ltd.'s seafood processing facility in Samutsakorn, Thailand, and found serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123). The FDA issued an FDA-483, Inspectional Observations, and deemed the firm's October 15, 2013, response inadequate.

The violations render the firm's mackerel products adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act).

Key deviations include: 1. **Failure to list critical control points for scombrotoxin (histamine) formation:** The revised HACCP plan for mackerel did not identify critical control points to control histamine formation, particularly concerning cumulative exposure times to ambient unrefrigerated temperatures during processing steps like (b)(4). FDA recommends fish not exceed 24 hours cumulatively above 40°F (4.4°C), with no portion above 70°F (21.1°C). 2. **Failure to identify undeclared major food allergens:** The HACCP plan did not identify undeclared major food allergens, such as fish protein and soy ingredients, as a food safety hazard.

Royal Foods Co. Ltd. must respond in writing within 15 working