FDA EIR - Adare Pharmaceuticals, Inc. - January 25, 2019

Adare Pharmaceuticals Inc., located in Vandalia, OH, was subject to a U.S. FDA surveillance inspection from January 22 to January 25, 2019. This inspection, conducted under the regulatory framework for Drug Manufacturing Inspections (CPGM 7356.002), focused on the company's manufacturing of finished oral solid dosage form pharmaceuticals. The primary systems reviewed included quality and production, with some coverage of laboratory and facilities/equipment. The inspection concluded without the issuance of an FDA Form 483, signifying no major regulatory violations; thus, it was classified as No Action Indicated (NAI).

However, three key discussion items were raised with company management. Firstly, the firm's complaint procedure needed to include a formal timeframe for documenting and investigating complaints upon receipt. Secondly, the inspection highlighted an instance of not adhering to the 30-day timeframe for closing a complaint without an approved extension, emphasizing the importance of consistently following written procedures. Lastly, laboratory investigations into system suitability failures were found to lack sufficient detail regarding the specific problem and the corrective actions implemented. Adare Pharmaceuticals' management acknowledged these points and committed to updating the complaint procedure, reinforcing adherence to SOPs, and ensuring more detailed documentation for future laboratory investigations.