FDA EIR - Avadel Pharmaceuticals PLC - October 11, 2018

An FDA inspection of Avadel Pharmaceuticals PLC was conducted from October 10-11, 2018, as a follow-up to a previous medical device compliance inspection. The prior inspection, concluded in October 2017 under the CPGM 7382.845 framework for medical device manufacturers, had resulted in five significant observations. These included inadequate establishment of corrective and preventive action (CAPA) procedures, manufacturing and distributing a Class 2 medical device (Flexichamber) without a Device Master Record, failing to validate molding machines for revised specifications, neglecting design reviews despite implementing changes, and not updating the risk analysis to reflect a Class 2 recall. However, during this follow-up inspection, Avadel Pharmaceuticals PLC reported that in February 2018, they had sold their entire pediatric portfolio, including the Flexichamber, to Cerecor Inc. Consequently, Avadel is no longer registered with the FDA as a medical device specification developer and has transferred all associated regulatory responsibilities and documents to Cerecor Inc. and its subsidiary, Zylera Pharmaceuticals. Due to this divestiture, the FDA investigator could not verify the correction of the five previous observations by Avadel. The responsibility for addressing these issues now lies with the new owners, Cerecor Inc. and Zylera Pharmaceuticals, who are currently registered as the device's specification developer.