FDA Inspection 1217806 — Eli Lilly & Company
The FDA completed an inspection of Eli Lilly & Company on September 15, 2023 in Indianapolis, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 15, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Bioresearch Monitoring
- Location
- Indianapolis, IN (United States)
Additional Details
Risk Evaluation and Mitigation Strategies (REMS)
Citations
| ID | CFR | Description |
|---|---|---|
| 21354 | FDCA 505-1(f)(3)(A) | Failure to comply with REMS Elements to Assure Safe Use (ETASU) A |
| 21355 | FDCA 505-1(f)(3)(B) | Failure to comply with REMS Elements to Assure Safe Use (ETASU) B |
| 21356 | FDCA 505-1(f)(3)(C) | Failure to comply with REMS Elements to Assure Safe Use (ETASU) C |
| 21357 | FDCA 505-1(f)(3)(D) | Failure to comply with REMS Elements to Assure Safe Use (ETASU) D |
| 21359 | FDCA 505-1(f)(3)(F) | Failure to comply with REMS Elements to Assure Safe Use (ETASU) F |