Vita Food Products, Inc. – FDA Warning Letter, Jul 10, 2014

On June 16-July 10, 2014, FDA inspected Vita Food Products, Inc., a seafood processor and importer. 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 July 22, 2014, response was inadequate, lacking documentation of implemented corrective actions or a timetable.

The cold smoked Salmon products are adulterated under 21 U.S.C. § 342(a)(4) due to preparation, packing, or holding conditions that may render them injurious to health.

Significant deviations include: 1. **Inadequate HACCP Plan (21 CFR 123.6(a) and (c)(2)):** The Cold Smoked Salmon HACCP plan failed to list critical control points (CCPs) for pathogen growth and toxin formation during time and temperature abuse in storage. FDA recommends separate CCPs for each storage step with a critical limit of 40°F or below and continuous ambient temperature monitoring. 2. **Unapproved Food Additive Use:** The use of acidified sodium chlorite (ASC) solutions on cold smoked salmon outside of prescribed uses (21 CFR 173.325) is considered an unapproved food additive. The HACCP