Lilly Del Caribe, Inc.
Lilly Del Caribe, Inc. has 0 FDA recalls, 20 inspections, 0 510(k) clearances and 1 compliance action on record.
- Latest inspection
- May 12, 2026 · NAI
Newer recall under related name Eli Lilly And: Mar 12, 2024, D-0445-2024.
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 20 | Nov 13, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 2 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 1 | 0 | 0 | 0 | 0 |
| 2022 | 1 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 0 | 0 | 0 | 0 |
| 2018 | 2 | 0 | 0 | 0 | 0 |
| 2017 | 1 | 0 | 0 | 0 | 0 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| May 12, 2026 | Carolina, PR | Drugs | No Action Indicated (NAI) | 3004525072 |
| Jan 30, 2026 | Carolina, PR | Drugs | Voluntary Action Indicated (VAI) | 2619243 |
| Feb 17, 2023 | Carolina, PR | Drugs | Voluntary Action Indicated (VAI) | 3004525072 |
| Feb 25, 2022 | Carolina, PR | Drugs | Voluntary Action Indicated (VAI) | 2619243 |
| Jul 12, 2019 | Carolina, PR | Drugs | Voluntary Action Indicated (VAI) | 2619243 |
| Sep 27, 2018 | Carolina, PR | Drugs | No Action Indicated (NAI) | 3004525072 |
| Sep 21, 2018 | Carolina, PR | Drugs | Voluntary Action Indicated (VAI) | 2619243 |
| Jul 21, 2017 | Carolina, PR | Drugs | Voluntary Action Indicated (VAI) | 2619243 |
| Jun 1, 2016 | Carolina, PR | Drugs | Voluntary Action Indicated (VAI) | 3004525072 |
| Nov 10, 2015 | Guayama, PR | Drugs | No Action Indicated (NAI) | 3005303436 |
| May 1, 2015 | Carolina, PR | Drugs | No Action Indicated (NAI) | 2619243 |
| Feb 21, 2014 | Carolina, PR | Drugs | No Action Indicated (NAI) | 3004525072 |
| Jul 22, 2013 | Carolina, PR | Drugs | Voluntary Action Indicated (VAI) | 2619243 |
| May 9, 2013 | Guayama, PR | Drugs | No Action Indicated (NAI) | 3005303436 |
| Apr 4, 2012 | Carolina, PR | Drugs | Voluntary Action Indicated (VAI) | 3004525072 |
| Apr 28, 2011 | Carolina, PR | Drugs | Voluntary Action Indicated (VAI) | 3004525072 |
| Dec 3, 2010 | Guayama, PR | Drugs | Voluntary Action Indicated (VAI) | 3005303436 |
| Sep 23, 2010 | Carolina, PR | Drugs | Voluntary Action Indicated (VAI) | 2619243 |
| Sep 15, 2010 | Carolina, PR | Drugs | No Action Indicated (NAI) | 3004525072 |
| Jul 31, 2009 | Carolina, PR | Drugs | Official Action Indicated (OAI) | 3004525072 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
Compliance Actions
FDA's compliance actions data lists 1 compliance action under Lilly Del Caribe, Inc.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3004525072 | Carolina, PR | 9 | May 12, 2026 |
| FEI 2619243 | Carolina, PR | 8 | Jan 30, 2026 |
| FEI 3005303436 | Guayama, PR | 3 | Nov 10, 2015 |
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