FDA 483 - Fedex Supply Chain, Inc. - July 23, 2021

Fedex Supply Chain, Inc. in Memphis, TN, a repackager/relabeler of medical devices, was cited for two observations during an FDA inspection. The firm failed to adequately validate a freezer used for temperature-sensitive Class II medical devices, specifically regarding capacity testing. Additionally, process validation results for freezer units were not adequately documented, with initial system settings being photocopied without contemporaneous records.