FDA EIR - AmbioPharm, Inc - July 05, 2017

AmbioPharm, Inc. underwent a pre-approval and cGMP inspection by the FDA from June 26 to July 5, 2017. The inspection, conducted under established compliance programs for active pharmaceutical ingredient (API) manufacturers, focused on the company’s processes and systems, including Quality, Facilities & Equipment, Materials, Production, and Laboratory Controls. As a facility registered for non-sterile API manufacturing, AmbioPharm is subject to the US Food, Drug, and Cosmetic Act.The inspection revealed significant deficiencies, documented in an FDA-483 form issued to Dr. Robert J. Geiger, Vice President of QA. Key violations included the failure to ensure the microbiological suitability of purification water used in API processing, and to adequately qualify and clean solvent tank silos, which led to material contamination. The company's systems for material re-evaluation, change control, corrective and preventive actions (CAPA), and employee training were found inadequate. Additional issues involved the insufficient investigation of differential pressure excursions, a lack of scientific justification for environmental monitoring frequency, and the absence of validation for laboratory spreadsheets. Furthermore, maintenance failures like rust and chipping paint in production areas posed risks of cross-contamination.Dr. Geiger committed to implementing comprehensive corrective actions and providing a written response within 15 working days to address these observations, ensuring compliance with good manufacturing practices.