FDA EIR - Avanos Medical, Inc. - October 02, 2018

An FDA "For Cause" inspection of Avanos Medical, Inc., a specification developer of Class 2 enteral feeding tubes based in Alpharetta, GA, was conducted from September 20 to October 2, 2018. This inspection, initiated by a consumer complaint and performed under the framework of medical device manufacturing regulations (CP7382.845, FD&C Act), also served to verify corrections from a prior 2016 inspection that cited deficiencies in Medical Device Reporting (MDR). The current inspection extensively reviewed the company's design controls, corrective and preventive actions (CAPA), production and process controls, complaint handling, MDR processes, and other quality system elements. While most areas showed no significant deficiencies, a critical issue was identified concerning the firm's sterilization validation procedures. Specifically, Avanos Medical failed to adequately establish and follow procedures for monitoring and controlling process parameters for a validated process. This included a requalification event occurring outside the specified timeframe and the omission of required nonconformance initiation, constituting a violation of 21 CFR 820.75(b). Avanos Medical management acknowledged the observation and committed to providing a written response to the FDA within 15 business days. They also understood the need to provide objective evidence of implementing corrected procedures and ensuring consistent adherence for future validation activities.