FDA WARNING_LETTER - Nick & Katie's, Inc - June 05, 2012

On September 13, 2012, the FDA issued a Warning Letter to Nick & Katie's, Inc. following an inspection from May 16 to June 5, 2012, at their seafood processing facility in New Orleans, Louisiana. The inspection revealed serious deviations from FDA's Low-Acid Canned Food (21 CFR 108 and 113), Acidified Foods (21 CFR 108 and 114), and Current Good Manufacturing Practice (CGMP) (21 CFR 110) regulations, as well as the seafood Hazard Analysis and Critical Control Point (HACCP) regulation (21 CFR 123).

Key violations include: 1. **Failure to file a scheduled process for acidified food:** Specifically, no scheduled process was filed for the firm's Olive Salad product, as required by 21 CFR 108.25(c)(2). 2. **Failure to register as a commercial processor of acidified foods:** The firm did not register with the FDA, violating 21 CFR 108.25(c)(1). 3. **Lack of a scheduled process established by a qualified expert:** The Olive Salad product lacked a scheduled process established by an acidified foods expert, as required by 21 CFR 114.83. The firm's proposed reformulation lacked supporting