Lilly del Caribe, Inc.
Form 483 issued February 25, 2022 · Carolina, Puerto Rico
- Inspection
- Feb 25, 2022
- Investigator
- Libia M. Lugo
- Observations
- 2
- Pages
- 5
- FEI number
- 2619243
In short: On February 25, 2022, FDA issued a Form 483 with 2 observations to Lilly del Caribe, Inc. in Carolina, Puerto Rico (FEI 2619243) after an inspection that ran Feb 25, 2022. The investigator was Libia M. Lugo. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.160(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Investigations of an unexplained discrepancy and a failure of a batch or any of its components…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate standards designed to assure…
This inspection in context
Libia M. Lugo
24 documents · 2013–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
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 211.192
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 laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Lilly del Caribe, Inc.?
Libia M. Lugo is named on this Form 483, for the inspection of Feb 25, 2022. Each investigator has a profile showing what they cite most.
When was Lilly del Caribe, Inc. inspected by FDA?
The inspection ran Feb 25, 2022, and the Form 483 is dated February 25, 2022.
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.