Lilly 483 report offers insights from site making COVID antibodies

The US Food and Drug Administration (FDA) on 12 August released a Form 483 report to Eli Lilly’s sterile injectables site in Indianapolis, noting multiple quality lapses.

The observations follow a February to March 2021 inspection at the site, which makes several medications: bamlanivimab and etesevimab for COVID-19, glucagon for treating severe hypoglycemia in diabetic patients, and ramucirumab for non-small cell lung cancer.