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# Lilly Covid Plant Fails FDA Reinspection
- URL: https://www.fdaweb.com/lilly-covid-plant-fails-fda-reinspection/
- Published: 2020-10-14T12:00:00.000Z
- Updated: 2026-09-14T16:32:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147871

An FDA reinspection at a troubled Eli Lilly drug manufacturing plant in Branchburg, NJ has found additional GMP problems that could pose a hurdle for a promising Covid-19 drug that will be made there, according to a [report](https://www.reuters.com/article/us-health-coronavirus-lilly-exclusive/exclusive-fda-faults-quality-control-at-lilly-plant-making-trump-touted-covid-drug-idUKKBN26Y30C?ref=fdaweb.com) from Reuters. Last week, Lilly said it has asked FDA for an emergency use authorization (EUA) for its bamlanivimab neutralizing IgG1 monoclonal antibody as monotherapy in higher-risk patients who have recently been diagnosed with mild-to-moderate Covid-19 ([see earlier story](https://www.fdaweb.com/lilly-seeking-neutralizing-antibody-monotherapy-eua/)). The company [says](https://investor.lilly.com/news-releases/news-release-details/lilly-provides-comprehensive-update-progress-sars-cov-2?ref=fdaweb.com) it expects to submit an EUA request for combination therapy with its etesvimab recombinant fully human monoclonal neutralizing antibody in November pending clinical trial enrollment once additional safety data accumulate and sufficient supply is manufactured. Bamlanivimab is similar to Regeneron’s investigational antibody cocktail REGN-COV2 that president Trump was given after contracting the coronavirus earlier this month.

The Lilly plant was first inspected last November and its Form FDA-483 detailed numerous inspection findings, according to Reuters which reviewed the heavily redacted form. For example, the FDA-483 says data on the plant’s various manufacturing processes had been deleted and not appropriately audited. “The deleted incidents and related audit trail were not reviewed by the quality unit,” FDA inspectors wrote. Lilly did not always have proper laboratory controls for drugs manufactured at the plant, the FDA-483 says. One source told Reuters that the plant failed to maintain systems meant to ensure that a popular anti-migraine drug, Emgality, met strength and purity standards. The agency classified the inspection as “Official Action Indicated,” the most serious classification.

Lilly told Reuters that it has launched a “comprehensive remediation plan,” increased staffing at the site, and is working “aggressively” to address all concerns raised during the inspection. “These findings do not impact product quality or patient safety, as outlined in a detailed assessment submitted to FDA,” the company said. “Lilly continues to provide updates to the FDA on progress towards completion of our detailed plan.” A source told Reuters that Lilly employees had complained about problems at the plant, including insufficient staffing and falsified records. Lilly said the agency has not made any findings about falsifications at the site.

Reuters said the Lilly plant specializes in a range of drugs that are injected by syringe or infused intravenously. Such products require tighter controls due to contamination risks. Lilly acquired the New Jersey site when it bought ImClone Systems in 2008, and over the next 10 years FDA inspected the facility several times and found no serious problems.