Lilly del Caribe, Inc.
Form 483 issued February 17, 2023 · Carolina, Puerto Rico
- Inspection
- Feb 8 – Feb 17, 2023
- Investigators
- Angelica M. Hernandez· Jose Velez· Marian E. Ramirez
- Observations
- 2
- Pages
- 4
- FEI number
- 3004525072
In short: On February 17, 2023, FDA issued a Form 483 with 2 observations to Lilly del Caribe, Inc. in Carolina, Puerto Rico (FEI 3004525072) after an inspection that ran Feb 8 – Feb 17, 2023. The investigators were Angelica M. Hernandez, Jose Velez and Marian E. Ramirez. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×) · 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality unit failed to thoroughly review any unexplained discrepancy whether or not the drug substance…
- 02
The quality unit(s) should review and approve all appropriate batch records…
This inspection in context
Angelica M. Hernandez
15 documents · 2022–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
The firmLilly del Caribe, Inc. history
The site's inspection history, in date order.
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. 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.?
Angelica M. Hernandez, Jose Velez and Marian E. Ramirez are named on this Form 483, for the inspection of Feb 8 – Feb 17, 2023. Each investigator has a profile showing what they cite most.
When was Lilly del Caribe, Inc. inspected by FDA?
The inspection ran Feb 8 – Feb 17, 2023, and the Form 483 is dated February 17, 2023.
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.