Lilly Del Caribe
Puerto Rico 8 employees Updated 9 July 2026
Lilly Del Caribe is a finished-dose manufacturer based in Puerto Rico. It appears in 21 regulatory filings across 1 regulator, without an active US DMF or CEP on file. Its GMP standing is certified by ANVISA (Brazil) and US FDA. Its most recent recorded inspection, by US FDA, closed on 30 January 2026 as VAI.
4
registered plants
2 with an FDA FEI number
21
filings
across 1 regulators
These figures were checked against the regulators' own files on 25 July 2026
Inspections
8 of 8 confirmed
Sources: FDA Establishment Registration, read 4 May 2026. FDA drug inspection classifications, read 4 May 2026.
Inspection history
- 30 January 2026 VAI US FDA
- 17 February 2023 VAI US FDA
- 25 February 2022 VAI US FDA
- 12 July 2019 VAI US FDA
- 27 September 2018 NAI US FDA
- 21 September 2018 VAI US FDA
- 21 July 2017 VAI US FDA
- 1 June 2016 VAI US FDA
NAI means no action indicated, VAI means voluntary action indicated, and OAI means
official action indicated.
Registered plants
| Site | FDA FEI |
| CAROLINA, Puerto Rico | Not on file |
| (PR02) Carolina, United States | Not on file |
| Carolina, United States | 3004525072 |
| Carolina, United States | 2619243 |
Filings and GMP by regulator
| Regulator | Filings | GMP certificates |
| ARCSA (EC) | 21 | None |
| ANVISA (Brazil) | None | 1 |
| US FDA | None | 1 |
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Open risk flags
- The most recent inspection outcome was VAI, on 30 January 2026.
Sources on this page
- FDA
- Drug master files, establishment registration, inspection classifications
- EDQM
- Certificates of suitability
- EudraGMDP and national regulators
- GMP certificates