Eli Lilly and Company
Form 483 issued March 16, 2021 · I ndianapol i s, Indiana
- Inspection
- Mar 16, 2021
- Investigators
- Muna Algharibeh· Rafeeq Habeeb· Robert J. Ham
- Observations
- 7
- Pages
- 14
- FEI number
- 1819470
In short: On March 16, 2021, FDA issued a Form 483 with 7 observations to Eli Lilly and Company in I ndianapol i s, Indiana (FEI 1819470) after an inspection that ran Mar 16, 2021. The investigators were Muna Algharibeh, Rafeeq Habeeb, Robert J. Ham and Sandra A. Boyd. Most observations concern quality system and laboratory controls.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to establish an adequate system for monitoring environmental conditions…
- 02
Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training…
This inspection in context
Muna Algharibeh
15 documents · 2021–2026
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 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Eli Lilly and Company?
FDA listed 7 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Eli Lilly and Company?
Muna Algharibeh, Rafeeq Habeeb, Robert J. Ham and Sandra A. Boyd are named on this Form 483, for the inspection of Mar 16, 2021. Each investigator has a profile showing what they cite most.
When was Eli Lilly and Company inspected by FDA?
The inspection ran Mar 16, 2021, and the Form 483 is dated March 16, 2021.
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.