Lilly del Caribe, Inc.
Form 483 issued July 22, 2013 · Carolina, Puerto Rico
- Inspection
- Jul 9 – Jul 22, 2013
- Investigators
- Libia M. Lugo· Raquel Gonzalez Rivera
- Observations
- 4
- Pages
- 6
- FEI number
- 2619243
In short: On July 22, 2013, FDA issued a Form 483 with 4 observations to Lilly del Caribe, Inc. in Carolina, Puerto Rico (FEI 2619243) after an inspection that ran Jul 9 – Jul 22, 2013. The investigators were Libia M. Lugo and Raquel Gonzalez Rivera. Most observations concern quality system.
At a glance
Observations span 1 system, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
Investigations of an unexplained discrepancy did not extend to other batches of the same drug product…
- 02
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
Your facilities are not adequate to ensure the prevention of contamination of by environmental conditions that…
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 4 observations on this Form 483, mostly about quality system. The opening words of each observation are shown on this page.
Who inspected Lilly del Caribe, Inc.?
Libia M. Lugo and Raquel Gonzalez Rivera are named on this Form 483, for the inspection of Jul 9 – Jul 22, 2013. Each investigator has a profile showing what they cite most.
When was Lilly del Caribe, Inc. inspected by FDA?
The inspection ran Jul 9 – Jul 22, 2013, and the Form 483 is dated July 22, 2013.
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.