FDA 483 - Amcor Flexibles, LLC. - August 26, 2022

An FDA inspection of Amcor Flexibles, LLC., a medical device manufacturer in Commerce, CA, revealed three significant observations. The firm was cited for inadequate procedures to control non-conforming product, sampling plans not based on valid statistical rationale, and poorly established schedules for equipment maintenance. These issues indicate deficiencies in the firm's quality system.