FDA EIR - Eli Lilly And Company - September 26, 2022

A comprehensive surveillance inspection of Eli Lilly and Company was conducted by the FDA from September 26 to September 30, 2022. This high-priority review, operating under CPGM 7348.810 for Sponsors and Contract Research Organizations, assessed clinical investigator sites providing data for a Biologics License Application (BLA) supporting an Investigational New Drug (IND).

The inspection concluded with a "No Action Indicated" (NAI) classification, meaning no significant issues were found that warranted formal regulatory action. Critically, no Form FDA 483, an official list of inspectional observations, was issued. Furthermore, previous verbal discussion items from a January 2022 inspection, which had included concerns about IWRS validation, site monitoring, and lab certifications, were all found to be resolved during this current review.

During the closeout meeting, one verbal discussion item was presented: ensuring that all forms and contracts uploaded to the company's electronic VivaVault trial master file are certified as true and accurate copies of the original documents. Management was also reminded of their responsibilities to comply with the Federal Food, Drug, and Cosmetic (FD&C) Act, with a warning that non-compliance could lead to future regulatory actions. The company's primary action is to ensure proper certification of electronic documents and maintain overall adherence to the FD&C Act.