483
Amcor Flexibles, LLC.Amcor Flexibles, LLC. – FDA 483, Sep 14, 2017
Record Details
An FDA inspection of Amcor Flexibles, a medical device manufacturer in Commerce, California, identified a significant quality system deficiency. The firm failed to adequately document the monitoring and verification of the effectiveness checks for its corrective and preventive actions (CAPA). This indicates a breakdown in ensuring the long-term efficacy of implemented quality improvements.
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ID · 2b1a2514-c3c1-45fd-a28a-134d10f5224d
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