FDA 483 - Pharmadepot Labs, LLC - June 18, 2024

Pharmadepot Labs, LLC in San Diego, CA, was inspected by the FDA from June 10-18, 2024, and received a Form 483 with five observations. The inspection revealed significant deficiencies in the firm's quality control unit, production and process controls, laboratory controls, batch recordkeeping, and equipment calibration procedures, indicating a lack of fundamental GMP compliance for OTC drug manufacturing.