483
Safecor Health, LLCFDA 483 - Safecor Health, LLC - June 30, 2016
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An FDA inspection of SAFCOR Health LLC in Columbus, OH, a drug repackager, revealed two significant observations. The firm failed to thoroughly investigate product recalls and expand evaluations to other affected lots. Additionally, the company did not adequately validate cleaning methods for equipment and had issues with water system bioburden testing.
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ID · cd99bf24-180f-48d6-8c0c-2473de151284