FDA 483 - Lifecore Biomedical LLC - March 12, 2025

An FDA inspection of Lifecore Biomedical, LLC in Chaska, MN, from March 3-12, 2025, revealed two significant observations. The firm failed to adequately clean and maintain its water for injection (WFI) system and lacked a scientifically sound process to monitor it after maintenance. Additionally, the company did not consistently follow its written stability testing program, resulting in late and sometimes unjustified stability sample testing.