Eli Lilly and Company

Form 483 issued September 15, 2023 · Indianapolis, Indiana

Inspection: Sep 11 – Sep 15, 2023
Observations: 5
Pages: 5
FEI number: 1819470

In short: On September 15, 2023, FDA issued a Form 483 with 5 observations to Eli Lilly and Company in Indianapolis, Indiana (FEI 1819470) after an inspection that ran Sep 11 – Sep 15, 2023.

What FDA observed

Preview: the opening words of each observation

01
FDCA 505-1(f)(3)(A)
An application holder did not ensure healthcare providers (HCPs) who prescribe the drug are specially certified…
02
FDCA 505-1(f)(3)(B)
An application holder did not ensure pharmacies that dispense the drug are specially certified, as required…
03
FDCA 505-1(f)(3)(C)
An application holder did not ensure health care settings that dispense the drug are certified, as…
04
FDCA 505-1(f)(3)(D)
An application holder did not ensure each patient receiving the drug has evidence or other documentation…

1 more observation

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The firm

Eli Lilly and Company history

All 15 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

More form 483s

Browse other documents of this type.

Original PDF$99

✓ All 5 pages, as issued to the firm
✓ Searchable text
✓ Download right after checkout, yours to keep

I agree to the Terms of Service, the licence (internal use by my organization only, no sharing or resale) and the Refund Policy, and I ask for immediate access to the download, so I lose any right to cancel once it's available.

Get it free · first document

Secure checkout · receipt for expenses

Already bought it? Find an order

Licensed for use within your organization. No sharing or resale.

Complete the picture

483
Form 483 from this inspectionOct 6, 2023$99

Eli Lilly and Company site file

All 15 documents for this site in one go: $2,015 instead of ~~$2,687~~, 25% off.

See the site history

Questions about this 483

What did FDA find at Eli Lilly and Company?

FDA listed 5 observations on this Form 483. The opening words of each observation are shown on this page.

When was Eli Lilly and Company inspected by FDA?

The inspection ran Sep 11 – Sep 15, 2023, and the Form 483 is dated September 15, 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.