FDA 483 - OurPharma LLC - August 12, 2026

Between August 3 and August 12, 2026, the FDA conducted an inspection of OurPharma LLC, an outsourcing facility located in Fayetteville, Arkansas. The inspection identified three primary areas of concern regarding the facility"s compliance with safety and quality standards under the Federal Food, Drug, and Cosmetic Act. First, investigators found that the company performed sterilization processes in a room with inadequate cleanliness standards (ISO 8) without providing any scientific justification or risk assessment to ensure the drug products remained free from contamination. Second, the facility"s annual quality reports were riddled with significant errors, including mathematical mistakes, incorrect drug labels, and data that had been mistakenly copied from unrelated product files. These errors suggest a systemic failure by the quality control unit to review and verify essential records. Finally, the company lacked defined timelines for investigating failed test results. Some investigations into sterility failures remained open for over 200 days, creating a significant delay in determining the safety of drug batches. While these observations do not represent a final agency determination, OurPharma LLC is required to address these issues. The firm must provide a formal response to the FDA detailing its corrective actions or any objections to the findings to ensure future compliance with manufacturing regulations.