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QuVa Pharma, Inc., a registered outsourcing facility, produced sterile drug products with serious deficiencies in manufacturing practices that put patients at risk during an inspection conducted from August to October 2022. The facility's violations included inadequate controls for sterile drug production, which led to the company voluntarily recalling oxytocin 30 Units/500 mL due to incorrect product formulation in September 2022. The FDA determined that QuVa Pharma produced drugs that violated the Federal Food, Drug, and Cosmetic Act by failing to meet the conditions required for outsourcing facility exemptions under Section 503B.