FDA 483 - Oasis Medical, Inc. - January 27, 2025

An FDA inspection of Oasis Medical, Inc., a sterile drug manufacturer and distributor in Glendora, CA, was conducted from January 15-27, 2025. The inspection revealed significant deficiencies across the company’s quality, laboratory, production, and facilities/equipment systems, indicating a failure to comply with Current Good Manufacturing Practices (CGMP).

Key violations included a systemic failure to thoroughly investigate unexplained discrepancies and out-of-specification results, such as sterility failures and bioburden exceedances, for OTC Ophthalmic Lubricant drug products, with affected batches being released without adequate scientific justification. The firm’s quality unit lacked appropriately trained and educated personnel, failed to implement essential GMP training, and neglected to conduct annual product reviews or visual examinations of reserve samples, some of these being repeat observations from prior inspections.

Further issues encompassed an inadequate stability program, which lacked sufficient data to support product shelf life and omitted critical active ingredient identity and strength testing. Laboratory controls were compromised by unqualified equipment, poor maintenance, and unvalidated computer systems with shared access credentials. Production controls were found deficient, particularly in the visual inspection program (lacking defect criteria, acceptance limits, and personnel requalification) and process revalidations, including sterilization and hold time studies. Additionally, equipment qualification and cleaning validation were absent, and the cleanroom environmental monitoring program, along with material introduction methods, was inadequate, posing contamination risks.

Oasis Medical, Inc. is required to promptly address these serious observations by implementing robust corrective and preventive actions to ensure the quality, safety, and purity of its sterile drug products.