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# FDA Cites Olympia Pharma Over GMPs
- URL: https://www.fdaweb.com/fda-cites-olympia-pharma-over-gmps/
- Published: 2025-09-15T12:00:00.000Z
- Updated: 2026-09-14T15:21:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159868

FDA has issued Olympia Pharmaceuticals a three-item [Form FDA-483](https://www.fda.gov/media/188647/download?ref=fdaweb.com) following a 7/28-8/8 inspection of the firm’s Orlando, FL manufacturing facility. The inspection cited Olympia over the following GMP deficiencies:

- Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.
- Failing to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
- Aseptic processing areas are deficient regarding the system for cleaning and disinfecting.