FDA EIR - Avadel Pharmaceuticals PLC - October 06, 2017

An FDA inspection of Avadel Pharmaceuticals PLC, a specification developer for the Class 2 medical device Flexichamber, was conducted from October 2 to October 6, 2017, at its Chesterfield, MO facility. This pre-announced inspection, the first for Avadel at this site, focused on management controls, corrective and preventive actions (CAPA), and design controls, following a prior recall (Z-1995-2016) of the Flexichamber due to manufacturing inconsistencies.

The inspection revealed five significant violations documented on an FDA-483 form. Avadel was cited for inadequate corrective and preventive action procedures, managing the Flexichamber recall as an ad hoc effort outside established CAPA processes, and failing to initiate CAPAs for identified design control issues. Additionally, the company manufactured and distributed the Flexichamber without an adequately maintained Device Master Record until the inspection's eve. Further issues included qualifying molding machines without validating them to meet revised specifications, a complete absence of design reviews since June 2015 despite significant changes, and an outdated risk analysis that failed to incorporate the Class 2 recall event.

These findings indicate non-compliance with critical aspects of medical device quality system regulations. Avadel's management verbally committed to correcting all identified observations. The FDA reminded the firm of its responsibility to comply with the Federal Food, Drug, and Cosmetic Act, noting that failure to do so could lead to seizure, injunction, and/or civil and criminal penalties.