FDA 483 - Apertus Pharmaceuticals - October 31, 2025

During an inspection conducted from October 27 to October 31, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Apertus Pharmaceutical LLC, a drug manufacturer located in Ballwin, MO. The inspection revealed several significant observations indicating a failure to adhere to current Good Manufacturing Practices (cGMP) as outlined under the Federal Food, Drug, and Cosmetic Act.

Key observations included a lack of adequate written procedures for production and process controls. Specifically, a 2016 process validation for tablets and capsules identified an assay failure that was never investigated, and the process remains unvalidated. Furthermore, the company's written stability program was deemed inadequate, as it failed to include robust testing for impurities during release and stability testing, and omitted active ingredient assay testing during stability studies for tablets and capsules.

Apertus Pharmaceutical LLC was also cited for accepting supplier certificates of analysis for high-risk components without adequately verifying the supplier's analytical reliability, particularly concerning numerous lots of manufactured tablets and capsules. Lastly, deficiencies were noted within the quality control unit, specifically regarding incomplete and inconsistent data integrity practices. This included infrequent audit trail reviews for critical chromatography-based tests and a lack of documented justification for certain assay integrations.

These observations necessitate Apertus Pharmaceutical LLC to develop and implement comprehensive corrective and preventive actions to ensure the identity, strength, purity, and quality of its drug products, and to bring its operations into full compliance with regulatory requirements.