FDA WARNING_LETTER - Gold Kosher Catering, Inc. - March 19, 2015

On April 27, 2015, the FDA issued a Warning Letter to Gold Kosher Catering, Inc. following an inspection from March 11-19, 2015, at their Miami, FL seafood processing facility. The inspection revealed serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR Part 123) and the Current Good Manufacturing Practice regulation (21 CFR Part 110).

Specifically, the firm failed to conduct a hazard analysis and implement written HACCP plans as required by 21 CFR 123.6(a) and (b). Gold Kosher Catering, Inc. lacked a HACCP plan for cooked Tilapia to control pathogenic bacteria growth from time-temperature abuse, pathogenic survival through cooking, and allergens/additives. Additionally, no HACCP plan was in place for frozen breaded Pollack to control allergens/additives. These omissions render the cooked Tilapia and breaded Pollack adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 342(a)(4)), as they were prepared, packed, or held under insanitary conditions.

The FDA warned that failure to promptly correct these violations could lead to further actions, including product seizure and/or injunctions preventing the firm from operating. Gold Kosher Catering