FDA Inspection
Eli Lilly & CompanyEli Lilly & Company – FDA Inspection, May 20, 2025
Record Details
This FDA Inspection record concerns Eli Lilly & Company, with an inspection on May 20, 2025, issued by the Detroit District Office, covering human drugs.
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ID · 809cae3e-94ad-47cf-a116-8f4799dc570f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1270621
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.67(b)Written procedures not established/followed
- 21 CFR 211.84(d)(2)Establish reliability of supplier's C of A
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Other FDA inspections of Eli Lilly & Company
35| Date | Classification | Office | Project area |
|---|---|---|---|
| January 9, 2026 | NAI | Bioresearch Monitoring | |
| March 27, 2025 | Not classified | Detroit District Office | |
| January 15, 2025 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| October 6, 2023 | Not classified | Detroit District Office | |
| September 15, 2023 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Eli Lilly & Company
- FDA Inspection 1298628 - 2026-01-09
- FDA Inspection 1260339 - 2025-03-27
- FDA Inspection 1229895 - 2025-01-15
- FDA Inspection 1220489 - 2023-10-06
- FDA Inspection 1217806 - 2023-09-15
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