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# CGMP Violations at Oasis Medical
- URL: https://www.fdaweb.com/cgmp-violations-at-oasis-medical/
- Published: 2025-08-05T12:00:00.000Z
- Updated: 2026-09-14T15:18:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159624

A 1/16-1/27 FDA inspection at the Oasis Medical drug manufacturing facility in Glendora, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 7/15 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/oasis-medical-inc-707198-07152025?ref=fdaweb.com) says the specific violations were:

- failure to establish adequate written procedures for production and process control designed to assure that manufactured drug products have the identity, strength, quality, and purity they purport or are represented to possess;
- failure to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed;
- failure to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity, and failure to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates; and
- failure to establish an adequate quality control unit and to have in writing and fully follow the responsibilities and procedures applicable to the quality control unit.

FDA says that based on the nature of the violations and the firm’s failure to correct repeat violations, it recommends that Oasis engage a qualified consultant to assist it in meeting CGMP requirements.

Oasis was told to correct the violations promptly and to respond with a list of specific steps it has taken to correct the violations and prevent their recurrence, with a schedule for completing the corrections.