Lilly del Caribe, Inc.
Form 483 issued January 30, 2026 · Carolina, Puerto Rico
- Inspection
- Jan 27 – Jan 30, 2026
- Investigators
- Christian F. Gomez Lugo· Jose Velez
- Observations
- 2
- Pages
- 4
- FEI number
- 2619243
In short: On January 30, 2026, FDA issued a Form 483 with 2 observations to Lilly del Caribe, Inc. in Carolina, Puerto Rico (FEI 2619243) after an inspection that ran Jan 27 – Jan 30, 2026. The investigators were Christian F. Gomez Lugo and Jose Velez. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.22(d) (1×) · 211.56(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Buildings used in the manufacture, processing, packing or holding of drug products are not free of…
This inspection in context
Christian F. Gomez Lugo
6 documents · 2024–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in North Carolina.
The firmLilly del Caribe, Inc. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lilly del Caribe, Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Lilly del Caribe, Inc.?
Christian F. Gomez Lugo and Jose Velez are named on this Form 483, for the inspection of Jan 27 – Jan 30, 2026. Each investigator has a profile showing what they cite most.
When was Lilly del Caribe, Inc. inspected by FDA?
The inspection ran Jan 27 – Jan 30, 2026, and the Form 483 is dated January 30, 2026.
How do I get the full Form 483 for Lilly del Caribe, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.