Overview
- 15 FDA inspections are on record.
- 8 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-01-30.
At a glance
Inspections
15
Form 483s
8
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Jan 2026 – 30 Jan 2026 | Human Drugs | 483 | View 483 → |
| 12 Feb 2024 – 16 Feb 2024 | Human Drugs | 483 | On file |
| 9 Feb 2022 – 25 Feb 2022 | Human Drugs | 483 | View 483 → |
| 9 Jul 2019 – 12 Jul 2019 | Human Drugs | 483 | On file |
| 10 Sep 2018 – 21 Sep 2018 | Human Drugs | 483 | On file |
| 10 Jul 2017 – 21 Jul 2017 | Human Drugs | 483 | On file |
| 14 Mar 2016 – 18 Mar 2016 | Human Drugs | Clean | |
| 28 Apr 2015 – 1 May 2015 | Human Drugs | Clean | |
| 9 Jul 2013 – 22 Jul 2013 | Human Drugs | 483 | View 483 → |
| 23 Sep 2010 | Not recorded | 483 | View 483 → |
| 2 Nov 2007 | Not recorded | Clean | |
| 24 Aug 2006 | Not recorded | Clean | |
Observations on record
Form 483 observations cited at this site, most recent first.
30 Jan 2026
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Jose F Velez, Christian F Gomez Lugo
30 Jan 2026
21 CFR 211.56(a)
Sanitation--buildings not clean, free of infestation
Cited by Jose F Velez, Christian F Gomez Lugo
25 Feb 2022
21 CFR 211.160(b)
Scientifically sound laboratory controls
Cited by Libia M Lugo, Lareese K Thomas
25 Feb 2022
21 CFR 211.192
Extent of discrepancy, failure investigations
Cited by Libia M Lugo, Lareese K Thomas
22 Jul 2013
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Libia M Lugo, Raquel Gonzalez Rivera
Investigators
FDA investigators tied to this site in the record.
Jose E Melendez2 insp.
Marian E Ramirez2 insp.
Libia M Lugo2 insp.
Krishna Ghosh2 insp.
Noreen Muniz2 insp.
Raquel Gonzalez Rivera2 insp.
Ariel Cruz Figueroa2 insp.
Jose F Velez1 insp.
Christian F Gomez Lugo1 insp.
Daniel L Obrzut1 insp.
Yifan Wang1 insp.
Lareese K Thomas1 insp.
Rapti D Madurawe1 insp.
Ying Zhang1 insp.
Laurimer Kuilan-Torres1 insp.
Vilmary Negron Rodriguez1 insp.
German Rivera1 insp.
Ramon A Hernandez1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.125(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.160(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.56(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 212.30(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 314.81(b)(1)(ii) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Lilly del Caribe, Inc's 8 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat