Eli Lilly and Company
Form 483 issued October 21, 2022 · Indianapolis, Indiana
- Inspection
- Oct 17 – Oct 21, 2022
- Investigators
- Joseph A. Piechocki· Mercy Oyugi· Michael R. Shanks
- Observations
- 3
- Pages
- 2
- FEI number
- 1819470
In short: On October 21, 2022, FDA issued a Form 483 with 3 observations to Eli Lilly and Company in Indianapolis, Indiana (FEI 1819470) after an inspection that ran Oct 17 – Oct 21, 2022. The investigators were Joseph A. Piechocki, Mercy Oyugi, Michael R. Shanks and Nailing Zhang. Most observations concern production and facilities & equipment; 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×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm's aseptic technique in the' drug product filling OQerations is deficient. lsetup activities…
- 02
Aseptic processing areas for both thet>><•i ]Filling Line and th/><' lFilling .__ Line are deficient regarding…
- 03
Your firm's efficacy study's (Summary of Agent Efficacy Studies to Support (ndy Parenteral Manufacturing Site-2018, Document…
This inspection in context
Joseph A. Piechocki
19 documents · 2021–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
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 and facilities & equipment. 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?
Joseph A. Piechocki, Mercy Oyugi, Michael R. Shanks and Nailing Zhang are named on this Form 483, for the inspection of Oct 17 – Oct 21, 2022. Each investigator has a profile showing what they cite most.
When was Eli Lilly and Company inspected by FDA?
The inspection ran Oct 17 – Oct 21, 2022, and the Form 483 is dated October 21, 2022.
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.