Eli Lilly and Company
Form 483 issued February 23, 2001 · Indianapolis, Indiana
- Inspection
- Feb 23, 2001
- Investigators
- Patricia A. Cochran· Thomas J. Beis
- Observations
- 20
- Pages
- 25
- FEI number
- 1819470
In short: On February 23, 2001, FDA issued a Form 483 with 20 observations to Eli Lilly and Company in Indianapolis, Indiana (FEI 1819470) after an inspection that ran Feb 23, 2001. The investigators were Patricia A. Cochran and Thomas J. Beis. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and facilities & equipment account for 15 of 20 observations.
Most cited: 21 CFR 211.113 (6×) · 211.188 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
As noted by the following observations the Quality Unit. has failed to perform a _ comprehensive…
- 02
The NDA describes the facility “uses acceptance criteria for media fill of not more than ~…
- 03
The partially stoppered vials are not kept in a Class 100 environment during the mobile cart…
- 04
The aseptic media fill operations are video taped for review and/or comment in the event that…
This inspection in context
Patricia A. Cochran
3 documents · 2001
Cites 211.113 (control of microbiological contamination) 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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Eli Lilly and Company?
FDA listed 20 observations on this Form 483, mostly about production, facilities & equipment and quality system. 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?
Patricia A. Cochran and Thomas J. Beis are named on this Form 483, for the inspection of Feb 23, 2001. Each investigator has a profile showing what they cite most.
When was Eli Lilly and Company inspected by FDA?
The inspection ran Feb 23, 2001, and the Form 483 is dated February 23, 2001.
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.