Lilly del Caribe, Inc.
Form 483 issued September 21, 2018 · Carolina, Puerto Rico
- Inspection
- Sep 10 – Sep 21, 2018
- Investigator
- Noreen Muniz
- Observations
- 5
- Pages
- 5
- FEI number
- 2619243
In short: On September 21, 2018, FDA issued a Form 483 with 5 observations to Lilly del Caribe, Inc. in Carolina, Puerto Rico (FEI 2619243) after an inspection that ran Sep 10 – Sep 21, 2018. The investigator was Noreen Muniz. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory records are deficient in that they do not include a complete record of all…
- 02
Deviations from written laboratory mechanisms are…
- 03
Complaint records are deficient in that they do not include the findings of the investigation…
- 04
Written records of investigations into unexplained discrepancies do not always include the…
This inspection in context
Noreen Muniz
24 documents · 2008–2022
Cites 211.160 (general requirements) 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 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Lilly del Caribe, Inc.?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, quality system and production. The opening words of each observation are shown on this page.
Who inspected Lilly del Caribe, Inc.?
Noreen Muniz is named on this Form 483, for the inspection of Sep 10 – Sep 21, 2018. Each investigator has a profile showing what they cite most.
When was Lilly del Caribe, Inc. inspected by FDA?
The inspection ran Sep 10 – Sep 21, 2018, and the Form 483 is dated September 21, 2018.
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.