Eli Lilly and Company

Form 483 issued November 26, 2024 · Concord, North Carolina

Inspection
Nov 18 – Nov 26, 2024
Observations
1
Pages
2
FEI number
3027403675

In short: On November 26, 2024, FDA issued a Form 483 with 1 observation to Eli Lilly and Company in Concord, North Carolina (FEI 3027403675) after an inspection that ran Nov 18 – Nov 26, 2024. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.63 (equipment design, size, and location).

At a glance

1 of 1 observations on this 483 concern facilities & equipment.

Facilities & equipment1

Most cited: 21 CFR 211.63 (1×)

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

  1. 01

    Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…

The full 483

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This inspection in context

Questions about this 483

What did FDA find at Eli Lilly and Company?

FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.63 (equipment design, size, and location). The opening words of each observation are shown on this page.

When was Eli Lilly and Company inspected by FDA?

The inspection ran Nov 18 – Nov 26, 2024, and the Form 483 is dated November 26, 2024.

How do I get the full Form 483 for Eli Lilly and Company?

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