FDA 483 - Regenerative Processing Plant LLC - June 23, 2023

Regenerative Processing Plant LLC, an OTC drug manufacturer in Tampa, FL, was inspected by the FDA and received a Form 483 with four observations. The observations primarily concern inadequate control over drug product storage conditions, lack of equipment monitoring records, insufficient sanitation procedures, and incomplete distribution records. These issues indicate a need for improved adherence to Good Manufacturing Practices to ensure product quality and purity.