FDA 483 - McKesson Corporation dba RxPak - March 22, 2018

Rx Pak Division of McKesson Corporation, a drug repacker in Memphis, TN, received a Form FDA 483 following an inspection from March 19-22, 2018. The firm was cited for multiple quality control deficiencies, including inadequate procedures for preventing microbial contamination, failures in equipment maintenance documentation, and deficient investigation processes. Additionally, issues were noted regarding operator access to written procedures and the scientific justification for incoming material sampling strategies.