Eli Lilly and Company
Form 483 issued April 23, 2018 · Indianapolis, Indiana
- Inspection
- Apr 16 – Apr 23, 2018
- Investigators
- Corrine M. Carter· Myra K. Casey
- Observations
- 1
- Pages
- 3
- FEI number
- 1819470
In short: On April 23, 2018, FDA issued a Form 483 with 1 observation to Eli Lilly and Company in Indianapolis, Indiana (FEI 1819470) after an inspection that ran Apr 16 – Apr 23, 2018. The investigators were Corrine M. Carter and Myra K. Casey. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences).
What FDA observed
Preview: the opening words of each observation- 01
Not all (b) (4) adverse drug experience reports have been submitted within 30 days of the…
This inspection in context
Corrine M. Carter
2 documents · 2018–2025
Cites 314.80(c)(2) (postmarketing reporting of adverse drug experiences) more than any other section. Most of their documents are for sites in Indiana.
The firmEli Lilly and Company history
All 15 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 314.80(c)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Eli Lilly and Company?
FDA listed 1 observation on this Form 483. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences). The opening words of each observation are shown on this page.
Who inspected Eli Lilly and Company?
Corrine M. Carter and Myra K. Casey are named on this Form 483, for the inspection of Apr 16 – Apr 23, 2018. Each investigator has a profile showing what they cite most.
When was Eli Lilly and Company inspected by FDA?
The inspection ran Apr 16 – Apr 23, 2018, and the Form 483 is dated April 23, 2018.
How do I get the full Form 483 for Eli Lilly and Company?
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.