FDA 483 - Lifecore Biomedical LLC - January 21, 2021

Lifecore Biomedical LLC, a contract manufacturer in Chaska, MN, received two observations during an FDA inspection. The observations detail inadequate cleaning validation for aseptic equipment, specifically regarding atypical results that lacked proper investigation and scientific rationale. Additionally, the firm's supplier approval procedure failed to require change notification agreements for certain risk level suppliers, including those providing product components.