FDA EIR - Lifecore Biomedical LLC - November 22, 2019

This FDA pre-approval inspection of Lifecore Biomedical LLC, conducted from November 12-22, 2019, served as a targeted follow-up to a previous inspection (January-February 2019) that resulted in a 9-item FDA-483. The inspection aimed to verify the implementation of corrective actions for previous observations, guided by Compliance Programs for Pre-Approval, Drug Manufacturing, and Sterile Drug Process Inspections, and Good Manufacturing Practice regulations (21 CFR Part 211). The previous inspection cited issues including inadequate employee training, particularly for visual inspection (21 CFR 211.25(a)); deficiencies in preventing microbiological contamination (21 CFR 211.113(b)), such as non-conformance to sterilization and transfer equipment loading, inappropriate airflow studies, and poor aseptic techniques; insufficient validation of closure supplier reports (21 CFR 211.84(d)(3)); and failures in Quality Control Unit responsibilities (21 CFR 211.22(d)), specifically regarding risk assessments for process streams and container closure integrity failures. During this follow-up, Lifecore Biomedical demonstrated significant progress in addressing these concerns. Corrective actions included revising visual inspection training with new defect sets, updating procedures for equipment loading and aseptic techniques, re-executing airflow studies, and strengthening product risk assessments for container closure integrity. Notably, no FDA-483 was issued at the conclusion of this inspection, indicating substantial remediation efforts. However, some areas for continued improvement were identified, such as defining maximum allowable defects in visual inspection and ensuring complete labeling of defect library samples. The firm also noted atypical rejection rates in some aseptic process simulations due to non-commercial components, which they committed to rectify.