FDA 483 - Adare Pharmaceuticals, Inc. - February 25, 2025

An FDA inspection of Adare Pharmaceuticals, Inc. in Vandalia, OH, revealed significant deficiencies in the firm's quality system, specifically regarding the thorough review of unexplained discrepancies and investigation of batch failures. The firm repeatedly failed to adequately investigate issues such as system suitability failures, capsule quality problems, metallic particle contamination, and late stability sample testing. These failures often lacked appropriate root cause assessments and the implementation of effective corrective and preventive actions, indicating a systemic breakdown in their investigation processes.