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

Oasis Medical, Inc., located at 514 S. Vermont Avenue, Glendora, CA, was inspected by the FDA from January 15 to 27, 2025. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, as outlined in 21 CFR parts 210 and 211. These violations render the drug products adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.

Key issues identified include the failure to establish adequate written procedures for production and process control, leading to inconsistencies in drug identity, strength, quality, and purity. The firm relied excessively on visual inspections without addressing the root causes of visible particulates and critical defects. Additionally, Oasis Medical did not validate in-process hold times or commit to addressing potentially contaminated products already distributed.

The firm also failed to thoroughly investigate discrepancies or failures in batch specifications, particularly concerning sterility and bioburden test results. For instance, a sterility failure in VISCO SHIELD Topical Drops was inadequately investigated, with conflicting conclusions between the firm and its contract laboratory. Similarly, pre-sterilization bioburden results exceeding specifications were not properly addressed, lacking identification of microbes or potential root causes.

Furthermore, Oasis Medical did not establish laboratory controls with scientifically sound specifications and failed to implement an adequate stability testing program to determine appropriate storage conditions and expiration dates.

The FDA requires Oasis Medical to provide a comprehensive response addressing these violations, including corrective actions and timelines for implementation. The firm must ensure compliance with CGMP regulations to maintain product quality and safety.