FDA 483 - Pharmaceutical Specialties, Inc. - August 15, 2025

Pharmaceutical Specialties, Inc. in Rochester, MN, was inspected and cited for significant deficiencies in its manufacturing processes for OTC drug products. The inspection revealed failures in microbiological and component testing, inadequate investigations into out-of-specification results and equipment damage, and a deficient stability program. Additionally, the firm lacked proper process re-validation after specification changes and a comprehensive change management program.