An Update on Lilly’s Commitment to Quality Manufacturing

Eli Lilly and Company  | November 3, 2020

At Lilly, we are deeply committed to manufacturing high-quality medicines for patients who need them. Given recent interest in two routine U.S. Food and Drug Administration (FDA) general surveillance inspections of our manufacturing facility in Branchburg, NJ, we would like to provide an update on our remediation activities to date. We also wish to underscore the high degree of confidence we have in the quality of the active pharmaceutical ingredient (API) that we make in Branchburg and confirm the FDA’s observations did not impact the quality of API manufactured at Branchburg.

We have been working diligently to address a total of four FDA observations from the inspections and have performed in-depth investigations into each of the FDA’s areas of concern. For each observation, Lilly has either completed its remediation activities or has put enhanced interim controls in place while our improvements are completed. In each case, we have confirmed that there was never an impact on product quality. In addition, we are taking a comprehensive look at data integrity for the Branchburg site that addresses not only the specific findings but a broader review of manufacturing and laboratory systems at the site. The implementation of our plan is ongoing and is supported by an independent consultant to help ensure that our actions are effective and sustainable. Our goal is to ensure that the Branchburg facility meets all of the FDA’s rigorous Good Manufacturing Practices (GMP) and quality standards.

Our confidence in our supply chain is reinforced by the fact that all active pharmaceutical ingredient delivered from Lilly Branchburg is subject to further quality assurance steps when it is turned into a medicine at other sites. This constant testing throughout the manufacturing process gives Lilly a very high degree of confidence in the quality of products made with API from Lilly Branchburg.

As we urgently work toward providing treatments for COVID-19 and other life-threatening conditions, we are unwavering in our commitment to the safety of our medicines and our quality assurance systems for manufacturing excellence.

Read Lilly's previous statement regarding our commitment to quality manufacturing.

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. 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.