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

An FDA surveillance inspection of Adare Pharmaceuticals, Inc. in Vandalia, OH, was conducted from February 18-25, 2025. The inspection evaluated the prescription and Over-the-Counter (OTC) drug manufacturer's compliance with current Good Manufacturing Practices (cGMP) and the Drug Supply Chain Security Act (DSCSA), under Compliance Program 7356.002 and Section 582 of the FD&C Act. The inspection resulted in one FDA Form 483 observation and one verbal observation. The primary violation cited on Form 483, referencing 21 CFR 211.192, was the failure to thoroughly review unexplained discrepancies and instances where batches or components did not meet specifications. Specific issues included persistent, inadequately investigated system suitability failures in the laboratory (at least 25 incidents between January 2023 and February 2025, and 33 in the 2019 inspection), without effective corrective actions. Additionally, the firm failed to adequately investigate incidents of incorrect capsule markings and metallic particles in production equipment, not extending risk assessments to other potentially impacted batches. There were also consistent delays in stability sample testing, occurring in at least 18 months from January 2023 to February 2025, without implemented preventive measures. A verbal observation noted a deficiency in the facility's water sampling method, where samples were not consistently taken from the true point of use. Adare Pharmaceuticals management acknowledged the observations and committed to providing a written response to the FDA within 15 business days, and to update their water sampling procedures.