Lilly Del Caribe, Inc.

FDA Regulatory Profile

Lilly Del Caribe, Inc. has 0 FDA recalls, 20 inspections, 0 510(k) clearances and 1 compliance action on record.

What these totals cover: FDA records filed under the name "Lilly Del Caribe, Inc." and its spelling variant "Lilly Del Caribe". Records filed under related names are not included; see Related names.

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

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections20Nov 13, 2026Newest record Nov 5, 2026Current
Compliance actions1Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

Lilly Del Caribe, Inc.'s FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Lilly Del Caribe, Inc.: FDA inspections per year 2017: 1 inspections120172018: 2 inspections220182019: 1 inspections120192020: 0 inspections020202021: 0 inspections020212022: 1 inspections120222023: 1 inspections120232024: 0 inspections020242025: 0 inspections020252026: 2 inspections22026
YearInspectionsOAIWarning lettersRecall recordsClass I
202620000
202500000
202400000
202310000
202210000
202100000
202000000
201910000
201820000
201710000

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Recent FDA inspections

20 inspections from Jul 31, 2009 to May 12, 2026.

DateSiteProductClassificationFEI
May 12, 2026Carolina, PRDrugsNo Action Indicated (NAI)3004525072
Jan 30, 2026Carolina, PRDrugsVoluntary Action Indicated (VAI)2619243
Feb 17, 2023Carolina, PRDrugsVoluntary Action Indicated (VAI)3004525072
Feb 25, 2022Carolina, PRDrugsVoluntary Action Indicated (VAI)2619243
Jul 12, 2019Carolina, PRDrugsVoluntary Action Indicated (VAI)2619243
Sep 27, 2018Carolina, PRDrugsNo Action Indicated (NAI)3004525072
Sep 21, 2018Carolina, PRDrugsVoluntary Action Indicated (VAI)2619243
Jul 21, 2017Carolina, PRDrugsVoluntary Action Indicated (VAI)2619243
Jun 1, 2016Carolina, PRDrugsVoluntary Action Indicated (VAI)3004525072
Nov 10, 2015Guayama, PRDrugsNo Action Indicated (NAI)3005303436
May 1, 2015Carolina, PRDrugsNo Action Indicated (NAI)2619243
Feb 21, 2014Carolina, PRDrugsNo Action Indicated (NAI)3004525072
Jul 22, 2013Carolina, PRDrugsVoluntary Action Indicated (VAI)2619243
May 9, 2013Guayama, PRDrugsNo Action Indicated (NAI)3005303436
Apr 4, 2012Carolina, PRDrugsVoluntary Action Indicated (VAI)3004525072
Apr 28, 2011Carolina, PRDrugsVoluntary Action Indicated (VAI)3004525072
Dec 3, 2010Guayama, PRDrugsVoluntary Action Indicated (VAI)3005303436
Sep 23, 2010Carolina, PRDrugsVoluntary Action Indicated (VAI)2619243
Sep 15, 2010Carolina, PRDrugsNo Action Indicated (NAI)3004525072
Jul 31, 2009Carolina, PRDrugsOfficial 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.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

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.

Most recent: Warning Letter, Feb 5, 2010.

Individual actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

3 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3004525072Carolina, PR9May 12, 2026
FEI 2619243Carolina, PR8Jan 30, 2026
FEI 3005303436Guayama, PR3Nov 10, 2015

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.