FDA 483 - Renu Laboratories, Inc. - July 27, 2022

Renu Laboratories, Inc. in Warminster, PA, was inspected and received a Form 483 with seven repeat observations, indicating significant and persistent issues with their manufacturing practices for OTC drug products. The firm failed to properly investigate complaints, validate cleaning procedures, verify raw material identity, establish hold time limits, follow quality control procedures, conduct stability testing, and maintain GMP training records. These findings suggest a systemic lack of adherence to cGMP requirements.