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

Eli Lilly & Company in Indianapolis, IN, received a Form 483 with five observations following an FDA inspection from September 11-15, 2023. The firm failed to adhere to its approved Risk Evaluation and Mitigation Strategy (REMS) for Zyprexa Relprevv, specifically regarding the certification of healthcare providers, pharmacies, and healthcare settings. Additionally, the company did not ensure proper documentation of patient safe-use conditions or timely patient enrollment in the REMS registry, indicating significant non-compliance with drug safety protocols.