Lilly Del Caribe, Inc — FDA Facility Profile
Lilly Del Caribe, Inc is an FDA-inspected facility (FEI 2619243) located in Carolina, PR, US. RegDataLab tracks 8 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Jan 30, 2026: Voluntary Action Indicated (VAI)
- Inspections on record
- 8 (7 VAI, 1 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Import refusals
- 2
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Jan 30, 2026 | Voluntary Action Indicated (VAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) Sanitation--buildings not clean, free of infestation (21 CFR 211.56(a)) |
| Feb 25, 2022 | Voluntary Action Indicated (VAI) | Extent of discrepancy, failure investigations (21 CFR 211.192) Scientifically sound laboratory controls (21 CFR 211.160(b)) |
| Jul 12, 2019 | Voluntary Action Indicated (VAI) | No citations listed |
| Sep 21, 2018 | Voluntary Action Indicated (VAI) | No citations listed |
| Jul 21, 2017 | Voluntary Action Indicated (VAI) | No citations listed |
| May 1, 2015 | No Action Indicated (NAI) | No citations listed |
| Jul 22, 2013 | Voluntary Action Indicated (VAI) | Procedures not in writing, fully followed (21 CFR 211.22(d)) Prevention of contamination (21 CFR 212.30(a)) Extent of discrepancy, failure investigations (21 CFR 211.192) Contamination, chemical or physical change, deterioration (21 CFR 314.81(b)(1)(ii)) |
| Sep 23, 2010 | Voluntary Action Indicated (VAI) | Cleaning / Sanitizing / Maintenance (21 CFR 211.67(a)) Strict control not exercised over labeling issued (21 CFR 211.125(a)) |
Facility details
- Company
- Lilly Del Caribe, Inc
- Location
- Carolina, PR (US)
- Source
- inspections