Eli Lilly and Company
Form 483 issued June 16, 2023 · . Indianapolis, Indiana
- Inspection
- Jun 8 – Jun 16, 2023
- Investigators
- Debara Reese· Melina Rodriguez Upton· Wayne Seifert
- Observations
- 3
- Pages
- 2
- FEI number
- 1819470
In short: On June 16, 2023, FDA issued a Form 483 with 3 observations to Eli Lilly and Company in . Indianapolis, Indiana (FEI 1819470) after an inspection that ran Jun 8 – Jun 16, 2023. The investigators were Debara Reese, Melina Rodriguez Upton and Wayne Seifert. Most observations concern production and laboratory controls.
At a glance
2 of 3 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
A written procedure is not followed or is deficient for production and process controls designed to…
- 02
Observation 2: scanned text, readable in the full document.
- 03
An equipment validation is inadequate…
This inspection in context
Debara Reese
6 documents · 2015–2023
Cites 820.75(a) (process validation) 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 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Eli Lilly and Company?
FDA listed 3 observations on this Form 483, mostly about production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Eli Lilly and Company?
Debara Reese, Melina Rodriguez Upton and Wayne Seifert are named on this Form 483, for the inspection of Jun 8 – Jun 16, 2023. Each investigator has a profile showing what they cite most.
When was Eli Lilly and Company inspected by FDA?
The inspection ran Jun 8 – Jun 16, 2023, and the Form 483 is dated June 16, 2023.
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.