Lilly del Caribe, Inc.
FDA inspection history in Carolina, Puerto Rico, 2013 to 2026
- 5
- Form 483s
Every document, by year
- Form 483
2013: one Form 483; 2018: one Form 483; 2019: one Form 483; 2022: one Form 483; 2026: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2013One Form 483, at Carolina, Puerto Rico.
- 2018–19Two Form 483s, at Carolina, Puerto Rico.
- 2018The longest 483 on file: 5 observations over 5 pages at Carolina, Puerto Rico.
- 2022One Form 483, at Carolina, Puerto Rico.
- 2026One Form 483, at Carolina, Puerto Rico.
Cited most
Across all Lilly del Caribe observations on file
- 21 CFR 211.160General requirements4
- 21 CFR 211.192Production record review4
- 21 CFR 211.22Responsibilities of quality control unit3
- 21 CFR 211.110Sampling and testing of in-process materials and drug products2
- 21 CFR 211.194Laboratory records1
The complete Lilly del Caribe file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Carolina, Puerto Rico
Five Form 483s · 2013 to 2026 · 13 observations
Latest: Form 483, Jan 30, 2026 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-01-30 | 483 Form 483 | Carolina, Puerto Rico | 2 | $99 |
| 2022-02-25 | 483 Form 483 | Carolina, Puerto Rico | 2 | $99 |
| 2019-07-12 | 483 Form 483 | Carolina, Puerto Rico | — | $99 |
| 2018-09-21 | 483 Form 483 | Carolina, Puerto Rico | 5 | $99 |
| 2013-07-22 | 483 Form 483 | Carolina, Puerto Rico | 4 | $99 |
Investigators on these documents
Libia M. Lugo (2)Christian F. Gomez Lugo (1)Jose Velez (1)Noreen Muniz (1)Raquel Gonzalez Rivera (1)
FEI number 2619243 · most recent document Jan 30, 2026
About Lilly del Caribe, Inc.
How many FDA Form 483s has Lilly del Caribe, Inc. received?
FDA Intel has 5 Form 483s on file for Lilly del Caribe, Inc.; the most recent is dated Jan 30, 2026.
When was Lilly del Caribe, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Lilly del Caribe, Inc. is a Form 483 dated Jan 30, 2026, for the site in Carolina, Puerto Rico.
What did FDA cite at Lilly del Caribe, Inc.?
The regulations cited most in the observations on file for Lilly del Caribe, Inc. are 21 CFR 211.160 (General requirements), 4 times; 21 CFR 211.192 (Production record review), 4 times; 21 CFR 211.22 (Responsibilities of quality control unit), 3 times.