FDA EIR - Adare Pharmaceuticals, Inc. - May 19, 2017

An FDA surveillance inspection of Adare Pharmaceuticals Inc.'s Vandalia, OH facility was conducted from May 15-19, 2017. This review, aligning with FDA's drug manufacturing inspection guidelines, focused on the company's operations as a contract manufacturer of oral solid dosage forms. The inspection covered critical aspects including quality, laboratory, and production systems. Significantly, the inspection concluded without the issuance of an FDA Form 483, Inspectional Observations, and was ultimately classified as "No Action Indicated" (NAI). However, two key areas were discussed with management. Concerns were raised regarding the documentation of a "continuous improvement plan" intended to address raw material lot variability leading to dissolution failures. While the firm had successfully implemented internal blending to mitigate recent issues, the formal supplier improvement plan lacked comprehensive detail. Additionally, the inspection team noted a persistent issue with foreign particles in a critical ingredient blend from a supplier. Adare Pharmaceuticals acknowledged these observations, explaining their proactive internal measures such as enhanced incoming material testing and metal detection. They also confirmed ongoing efforts with the supplier to implement facility upgrades to resolve the foreign particle contamination. Management agreed to enhance the documentation for future improvement plans. No formal violations or immediate regulatory actions were required from the FDA.