FDA EIR - Lifecore Biomedical LLC - November 20, 2015

An FDA cGMP and pre-approval inspection of Lifecore Biomedical, Llc. in Chaska, MN, was conducted from November 16-20, 2015. The inspection, guided by 21 CFR Part 210 & 211 for finished pharmaceuticals, focused on the manufacturing of sterile drugs, particularly Sustol (granisetron) Injection, related to NDA 022445. The primary objective was to assess the firm's readiness for commercial manufacturing, conformance to application, and data integrity. The inspection identified a significant issue, resulting in a one-item FDA Form 483 observation: inadequate exhaust systems or controls for contaminants during production. Specifically, smoke studies for the aseptic syringe filler failed to adequately demonstrate airflow patterns under various operational conditions, a requirement under regulatory guidelines. Additionally, two issues were discussed with management: inconsistent documentation of equipment calibration and usage for a heat sealer, and the omission of a power loss simulation test during stability chamber qualification. Management acknowledged the observations, agreeing to repeat the insufficient smoke studies and implement corrections for the documentation and qualification discrepancies. The firm committed to providing a written response within 15 working days. A recommendation for approval for NDA 022445 was submitted to CDER, despite the noted deficiencies.