Eli Lilly and Company
Form 483 issued October 6, 2023 · Indianapolis, Indiana
- Inspection
- Oct 2 – Oct 6, 2023
- Investigators
- Qiao Bobo· Wayne Seifert
- Observations
- 3
- Pages
- 2
- FEI number
- 1819470
In short: On October 6, 2023, FDA issued a Form 483 with 3 observations to Eli Lilly and Company in Indianapolis, Indiana (FEI 1819470) after an inspection that ran Oct 2 – Oct 6, 2023. The investigators were Qiao Bobo and Wayne Seifert. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
2 of 3 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
A validation designed to prevent microbial contamination of drug products purponing to be sterile does not…
- 03
Observation 3: scanned text, readable in the full document.
This inspection in context
Qiao Bobo
2 documents · 2023–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in China.
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 211.113
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. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Eli Lilly and Company?
Qiao Bobo and Wayne Seifert are named on this Form 483, for the inspection of Oct 2 – Oct 6, 2023. Each investigator has a profile showing what they cite most.
When was Eli Lilly and Company inspected by FDA?
The inspection ran Oct 2 – Oct 6, 2023, and the Form 483 is dated October 6, 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.