FDA 483 - Lifecycle Biotechnologies, LP - January 24, 2022

Lifecycle Biotechnologies, LP, a drug component manufacturer in Loveland, CO, was inspected by the FDA from January 24-28, 2022. The inspection revealed significant deficiencies in manufacturing controls, facility maintenance, and quality unit oversight. Key issues included inadequate yield determination, poor facility repair, and failures in production record review and training documentation.