Eli Lilly and Company
Form 483 issued May 20, 2025 · Indianapolis, Indiana
- Inspection
- May 9 – May 20, 2025
- Investigators
- Elvis Patel· Jeffrey P. Raimondi· Junho Pak
- Observations
- 6
- Pages
- 32
- FEI number
- 1819470
In short: On May 20, 2025, FDA issued a Form 483 with 6 observations to Eli Lilly and Company in Indianapolis, Indiana (FEI 1819470) after an inspection that ran May 9 – May 20, 2025. The investigators were Elvis Patel, Jeffrey P. Raimondi, Junho Pak, Kara J. Wright, Michael T. Cyrus and Scott D. McGrew. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and quality system account for 4 of 6 observations.
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 not…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 04
Written records are not always made of…
This inspection in context
Elvis Patel
3 documents · 2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
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 6 observations on this Form 483, mostly about production, quality system 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?
Elvis Patel, Jeffrey P. Raimondi, Junho Pak, Kara J. Wright, Michael T. Cyrus and Scott D. McGrew are named on this Form 483, for the inspection of May 9 – May 20, 2025. Each investigator has a profile showing what they cite most.
When was Eli Lilly and Company inspected by FDA?
The inspection ran May 9 – May 20, 2025, and the Form 483 is dated May 20, 2025.
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.