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# Olympia Pharmaceuticals Hit With 483 Over Sterile Manufacturing
- URL: https://www.fdaweb.com/olympia-pharmaceuticals-hit-with-483-over-sterile-manufacturing/
- Published: 2026-10-02T14:27:05.000Z
- Updated: 2026-10-02T14:27:05.000Z
- Author: David McFarland
- Tags: Drugs

FDA has cited Olympia Pharmaceuticals for eight observations involving aseptic processing, environmental monitoring, component testing and other manufacturing controls following an inspection last month at the company's Orlando, FL, outsourcing facility.

The [Form 483](https://www.fda.gov/media/195123/download?ref=fdaweb.com) said Olympia’s aseptic processing areas had deficiencies in environmental and personnel monitoring. Investigators observed sterile filling-line processes taking place without concurrent environmental or personnel monitoring.

FDA also said the company had not adequately established/followed procedures designed to prevent microbiological contamination of sterile drugs. Among other findings, investigators questioned whether sterilized filling-machine components remained sterile during storage and found deficiencies in smoke studies intended to demonstrate appropriate airflow during aseptic operations.

Additionally, investigators cited discrepancies between written procedures and actual manufacturing practices, deficiencies in qualification of employees conducting visual inspections of injectable products and shortcomings in the stability program for Sermorelin Acetate injection.