Neogen Corporation
Form 483 issued December 21, 2023 · Lexington, Kentucky
- Investigator
- Logan T. Williams
- Observations
- 2
- Pages
- 3
- FEI number
- 3009631819
In short: On December 21, 2023, FDA issued a Form 483 with 2 observations to Neogen Corporation in Lexington, Kentucky (FEI 3009631819). The investigator was Logan T. Williams. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and production account for 2 of 2 observations.
Most cited: 21 CFR 211.67(a) (1×) · 211.113(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions and contamination that would…
- 02
Procedures designed to prevent objectionable microorganisms in drug products not required to be…
This inspection in context
Logan T. Williams
32 documents · 2020–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Kentucky.
The firmNeogen Corporation history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Neogen Corporation?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Neogen Corporation?
Logan T. Williams is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Neogen Corporation inspected by FDA?
This Form 483 is dated December 21, 2023.
How do I get the full Form 483 for Neogen Corporation?
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.