Lilly Del Caribe, Inc. — FDA Facility Profile
Lilly Del Caribe, Inc. is an FDA-registered facility (FEI 3004525072) located in Carolina, PR, US. Registered operations: ANALYSIS; API MANUFACTURE. RegDataLab tracks 9 FDA inspections and 1 compliance action at this facility.
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What FDA found at this site
- Latest inspection
- May 12, 2026: No Action Indicated (NAI)
- Inspections on record
- 9 (1 OAI, 4 VAI, 4 NAI)
- Last OAI inspection
- Jul 31, 2009
- Warning letters
- 1 listed by FDA for this FEI, latest Feb 5, 2010
- Import refusals
- 3
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| May 12, 2026 | No Action Indicated (NAI) | No citations listed |
| Feb 17, 2023 | Voluntary Action Indicated (VAI) | No citations listed |
| Sep 27, 2018 | No Action Indicated (NAI) | No citations listed |
| Jun 1, 2016 | Voluntary Action Indicated (VAI) | No citations listed |
| Feb 21, 2014 | No Action Indicated (NAI) | No citations listed |
| Apr 4, 2012 | Voluntary Action Indicated (VAI) | No citations listed |
| Apr 28, 2011 | Voluntary Action Indicated (VAI) | Documentation (21 CFR 820.100(b)) |
| Sep 15, 2010 | No Action Indicated (NAI) | No citations listed |
| Jul 31, 2009 | Official Action Indicated (OAI) | Investigations of discrepancies, failures (21 CFR 211.192) |
Facility details
- Company
- Lilly Del Caribe, Inc.
- Location
- Carolina, PR (US)
- Registration Expires
- Dec 31, 2026
- Operations
- ANALYSIS; API MANUFACTURE
- Source
- decrs