FDA 483 - Vee Pak LLC - December 11, 2023

During an FDA inspection from December 6-11, 2023, Vee Pak LLC, a human drug manufacturer in Countryside, IL, was cited for deficiencies in its written stability program. The firm failed to provide adequate stability data to demonstrate the microbiological properties of several drug products remain acceptable throughout their labeled expiry period, indicating a significant quality control issue.