OPS International Inc – FDA 483, Aug 8, 2025

The FDA conducted an inspection of Olympia Pharmaceuticals, an outsourcing facility located in Orlando, FL, from July 28 to August 8, 2025. The inspection revealed significant compliance issues related to aseptic processing and quality control procedures. Key observations included inadequate validation of aseptic processes, with air visualization studies showing improper airflow and setup of critical components, potentially compromising sterility. Additionally, the firm lacked adequate written procedures to ensure drug products meet identity, strength, purity, and quality standards. Specifically, the light conditions for inspecting amber-colored vials were insufficient, and the test kits used for inspector qualification were inadequate.

Furthermore, deficiencies were noted in the cleaning and disinfection practices within aseptic processing areas. Poor cleaning techniques were observed, such as operators contacting disinfected surfaces with their garments and using exposed wipes in cleanroom environments, which could compromise aseptic conditions.

These observations indicate non-compliance with the Federal Food, Drug, and Cosmetic Act, specifically Section 704(b), which mandates that facilities maintain sanitary conditions to prevent contamination. Olympia Pharmaceuticals is required to address these issues by implementing corrective actions to ensure compliance with FDA regulations. The firm is encouraged to discuss objections or corrective actions with FDA representatives or submit documentation to the FDA to demonstrate compliance efforts.