FDA 483 - Eli Lilly & Company - September 15, 2023

Eli Lilly & Company received an FDA Form 483 following an inspection conducted from September 11-15, 2023, concerning their commercial sponsor operations. The observations primarily focused on non-compliance with the Risk Evaluation and Mitigation Strategy (REMS) program for their drug, Zyprexa Relprevv.

Inspectors noted several critical issues related to the Elements to Assure Safe Use (ETASU) for Zyprexa Relprevv during the assessment reporting period of August 2021 to August 2022, and extending to the present for patient enrollment. Specifically, the FDA observed that the company failed to ensure healthcare providers were specially certified prior to prescribing the drug. Similarly, pharmacies dispensing Zyprexa Relprevv were not properly certified and, in some instances, dispensed the drug to non-registered patients. Healthcare settings administering the drug were also found to be uncertified.

Further observations included a lack of evidence or documentation confirming safe-use conditions for patients receiving the drug. Most notably, 46 patients received approximately 67 injections of Zyprexa Relprevv before being enrolled in the required REMS registry program, starting from August 2020. Eli Lilly & Company is expected to address these observations to ensure full compliance with regulatory requirements regarding drug safety and distribution protocols.