FDA 483 - Future Pak LLC - December 12, 2019

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.