FDA WARNING_LETTER - Cara Donna Provision Company - May 03, 2013

On June 4, 2013, the FDA issued a Warning Letter to Cara Donna Provisions Co. Inc. following an inspection from April 25 to May 3, 2013. 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).

The primary violation was that the firm's tuna salad and seafood salad products were deemed adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act, having been prepared, packed, or held under insanitary conditions.

Specific deficiencies included: 1. **Lack of Critical Limits:** HACCP plans for tuna salad and seafood salad lacked critical limits at the "Receiving/Putaway" critical control points, specifically for continuous monitoring of incoming delivery truck temperatures to ensure products remained at or below 40°F during transit. (21 CFR 123.6(c)(3)) 2. **Inadequate Monitoring Procedures:** HACCP plans did not list continuous monitoring procedures for the storage of products on the firm's delivery trucks, which are used for refrigerated storage prior to delivery. (21 CFR 123.6(c)(4)) 3. **Inadequate Corrective Actions:** The corrective actions listed in the HAC