FDA 483 - Olein Recovery Corp - March 18, 2021

Olein Recovery Corp, an OTC drug own label distributor in Yabucoa, PR, was cited for significant deficiencies in its quality control unit, GMP training, warehouse storage, and product distribution systems. The firm lacked written procedures for critical operations like complaints and recalls, failed to train employees on GMPs, and stored drug products with non-regulated items. Additionally, the company could not track products by lot number for recall purposes, indicating a fundamental lack of control over drug product quality and safety.