483
Future Pak LLCFDA 483 - Future Pak LLC - December 12, 2019
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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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