483
Amcor Flexibles, LLC.Amcor Flexibles, LLC. – FDA 483, Aug 26, 2022
Record Details
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.
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ID · 8044baeb-3690-4f27-9b3c-9971789b9e76
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