The Food and Drug Administration is requiring Eli Lilly (LLY) to hire consultants to test batches and vet quality-testing data at a manufacturing plant where its Covid-19 antibody treatment is being made, a mandate that comes after the agency found quality control problems during two separate inspections over the past year.
The stipulations were included in a Nov. 10 letter the agency sent to the drug maker authorizing the use of bamlanivimab for treating adults and children with mild-to-moderate cases of Covid-19. If reviews by independent consultants find any batch or data discrepancies with “significant potential to affect critical quality attributes,” the drug cannot be released until the problems are resolved.
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