OPS International Inc – FDA 483, May 28, 2024

An FDA inspection of Olympia Compounding Pharmacy, an outsourcing facility in Orlando, FL, conducted from May 14 to May 29, 2024, identified significant violations in manufacturing practices and quality controls, with several issues being repeat observations. The firm failed to reject and destroy drug products, such as a MICC lot, that did not meet potency specifications, distributing them instead. Critical deficiencies included a lack of written procedures for production and process controls, leading to unvalidated filling parameters, defective crimping, inadequate in-process sampling, and insufficient equipment maintenance. The inspection also revealed shortcomings in aseptic processing, such as unvalidated sterilization processes, residual liquid in lyophilizers, and incomplete cleaning validation for product contact surfaces. Environmental monitoring was deemed inadequate due to the omission of disinfectant neutralizers in viable surface swab samples. Furthermore, the firm's aseptic process validation did not ensure worst-case conditions like line speed were met during simulations. A major finding was the failure to properly investigate numerous complaints, including serious adverse drug events, with many complaints retrieved from a "Deleted Items" folder. Finally, Olympia Compounding Pharmacy failed to comply with Section 503B(b)(2)(A) of the Federal Food, Drug, and Cosmetic Act by not reporting several compounded drug products to the FDA. The firm is required to implement prompt corrective actions to address these observations and ensure regulatory compliance and product quality.