FDA EIR - Amcor Flexibles, LLC. - September 14, 2017

An FDA inspection was conducted at Amcor Flexibles, Commerce, from September 7 to September 14, 2017. The inspection focused on the company, a manufacturer of Class II self-sealing sterilization pouches, and covered their Corrective and Preventive Action (CAPA) and Production and Process Controls subsystems. The primary violation identified was the inadequate documentation, monitoring, and verification of the effectiveness checks for corrective and preventive actions. Specifically, several CAPA files lacked sufficient records demonstrating that their effectiveness was adequately assessed, a recurring issue from a previous FDA inspection in 2013 regarding the CAPA subsystem. This finding constitutes a violation of 21 CFR Part 820.100, which pertains to medical device quality system regulations. As a result, an FDA-483 Inspectional Observation was issued to the Plant Manager. Amcor Flexibles acknowledged the observation and committed to submitting a written response to the FDA within 15 days. The company also promised to update its CAPA procedures (SOP 200-006) to ensure clear instructions for conducting and documenting effectiveness checks, and to retroactively address the effectiveness verification for the specific CAPA files cited in the observation.