FDA 483 - Future Pak LLC - October 15, 2024

Future Pak LLC, a drug packager and labeler in Wixom, MI, received a Form 483 with six observations highlighting significant quality control deficiencies. The firm failed to adhere to established specifications for incoming materials and lacked adequate cleaning and maintenance procedures for equipment. Furthermore, the inspection revealed non-compliance with written production and process control procedures, insufficient review of unexplained discrepancies, and absent or unfulfilled in-process controls and quality unit procedures.