Eli Lilly & Company – FDA 483, Mar 16, 2021

This FDA Form 483 issued to Eli Lilly and Company in Indianapolis, IN, details critical deficiencies in their sterile human drug manufacturing. Observations include inadequate environmental monitoring in aseptic processing areas, failures in investigating discrepancies and batch failures, and a lack of appropriate procedures to prevent microbiological contamination. Further issues were identified in visual inspection training, the drug product stability program, and component sampling.