OPS International Inc – FDA 483, Sep 3, 2026

From August 20 to September 3, 2026, the FDA conducted an inspection of the Orlando, Florida facility of OPS International Inc, doing business as Olympia Pharmaceuticals. As a registered outsourcing facility, the firm is required to maintain rigorous quality control standards to ensure the safety and sterility of its manufactured drug products. The inspection identified several critical safety and quality concerns. Primary among these were deficiencies in the facility’s environmental and personnel monitoring systems. Specifically, the firm failed to perform air quality tests or technician gowning checks during the initial setup of sterile filling lines. Additionally, "smoke studies" intended to prove that clean air flows correctly over products during production were poorly executed and failed to demonstrate adequate protection against contamination. The FDA also noted significant issues regarding ingredient testing and product stability. The company failed to test certain raw materials, such as glycerin and alcohol, for potentially toxic contaminants. Furthermore, the methods used to determine product expiration dates were not proven to be scientifically reliable. Other violations included inconsistent record-keeping, inadequate qualification of visual inspectors to detect particles in finished vials, and a failure to contemporaneously verify the addition of ingredients during the manufacturing process. While these observations do not constitute a final agency determination, Olympia Pharmaceuticals is expected to respond to the FDA. The firm must provide a detailed plan of corrective actions to address these gaps in production, testing, and quality oversight to ensure future compliance with safety regulations.