FDA 483 - Positive Promotions - April 25, 2022

Positive Promotions, a repacker/relabeler of OTC drug products including hand sanitizers, sunscreens, and lip balms, was cited for significant deficiencies during an FDA inspection. The firm lacks a functional quality control unit, proper procedures for handling product complaints, and an adequate system for product traceability and recall. These issues indicate a severe lack of adherence to Good Manufacturing Practices for drug products.