FDA 483 - Lifecore Biomedical LLC - March 02, 2017

Lifecore Biomedical, Llc. in Chaska, MN, was inspected and cited for significant deficiencies in its manufacturing processes. The inspection revealed inadequate validation of key syringe product processes and packaging, with validation reports failing to meet acceptance criteria and necessary re-validations not being performed. Additionally, the firm failed to adequately establish and implement corrective and preventive action procedures, specifically by not opening CAPAs for identified major risks.