Lilly’s Commitment to Quality Manufacturing

Eli Lilly and Company  | October 20, 2020

More than 144 years ago, Colonel Eli Lilly founded our company on the principle of quality medicines that make life better for people around the world. We have never wavered in this responsibility as we have developed potential medicines to combat COVID-19 and other serious conditions.

Recently, one of our manufacturing plants underwent a routine U.S. Food and Drug Administration (FDA) general surveillance inspection to examine our adherence to rigorous Good Manufacturing Practices (GMP) and quality standards set by the FDA. The inspectors had some findings related to data handling and thus we received an Official Action Indicated (OAI) notice. Given that this plant, located in Branchburg, NJ, is among several worldwide that produces bamlanivimab, one of our COVID-19 neutralizing antibodies, we wanted to share more information about our response to this confidential inspection given global interest in our treatment development efforts.

The issues raised during the Branchburg inspections have our full attention and we have been working closely with FDA on remediation efforts. Lilly has engaged an external consultant to conduct a comprehensive independent review of systems at the Branchburg site, and we have increased staffing and resources at Branchburg to manage the additional activity levels we are experiencing related to production of active pharmaceutical (API) ingredients.

We are confident that the issues raised during the Branchburg inspections did not impact product quality or patient safety. While Lilly has not received a warning letter or other enforcement letter from the FDA related to this matter, we nevertheless take all FDA inspection findings very seriously and are urgently working to address their concerns.

We have a robust, global supply chain in place to produce bamlanivimab, with Branchburg being one of five API manufacturing sites worldwide. And in anticipation of a potential approval, we have engaged an independent consultant to review our detailed Branchburg manufacturing and quality records for bamlanivimab.

We are confident in the quality systems for our global manufacturing processes. Our commitment to the safety of our medicines has not – and will not – change during our efforts to provide treatments to fight this global pandemic.

Lilly Cautionary Statement Regarding Forward-Looking Statements
This statement contains forward-looking statements about the company’s manufacturing operations and reflects Lilly's current beliefs. However, as with any such undertaking, there are substantial risks and uncertainties related to pharmaceutical manufacturing. Among other things, there can be no guarantee that bamlanivimab will receive regulatory approvals or authorizations, or that we can provide an adequate supply of bamlanivimab in all circumstances. For a further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, please see Lilly's most recent Forms 10-K and 10-Q filed with the U.S. Securities and Exchange Commission. Lilly undertakes no duty to update forward-looking statements.