483
Future Pak LLCFuture Pak LLC – FDA 483, Dec 12, 2019
Record Details
The FDA inspected Future Pak, Ltd, a drug product packager in Wixom, MI, from December 9-12, 2019. The inspection revealed significant deficiencies in quality control unit procedures, facility design for preventing mix-ups and contamination, equipment qualification and verification, and cleaning and maintenance procedures for manufacturing equipment. These observations indicate a lack of adherence to good manufacturing practices.
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ID · a309f597-589b-4f5f-ae4e-5e000c076762
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