Neogen Corporation
FDA inspection history across 2 sites, 2001 to 2023
- 2
- Form 483s
- 2
- Warning letters
Every document, by year
- Form 483
- Warning letter
2001: one warning letter; 2016: one warning letter; 2021: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2001One warning letter, at Lansing, Michigan.
- 2016One warning letter, at Lansing, Michigan.
- 2021–23Two Form 483s, at Lexington, Kentucky.
- 2021The longest 483 on file: 5 observations over 5 pages at Lexington, Kentucky.
Cited most
Across all Neogen observations on file
- 21 CFR 211.122(d)Materials examination and usage criteria2
- 21 CFR 211.113(a)Control of microbiological contamination1
- 21 CFR 211.142(b)Warehousing procedures1
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.194(a)(4)Laboratory records1
The complete Neogen file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Lexington, Kentucky
Two Form 483s · 2021 to 2023 · 7 observations
Latest: Form 483, Dec 21, 2023 →Lansing, Michigan
Two warning letters · 2001 to 2016
Latest: Warning letter, Jan 26, 2016 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-12-21 | 483 Form 483 | Lexington, Kentucky | 2 | $99 |
| 2021-03-16 | 483 Form 483 | Lexington, Kentucky | 5 | $99 |
| 2016-01-26 | Warning letter Warning letter | Lansing, Michigan | — | $99 |
| 2001-12-06 | Warning letter Warning letter | Lansing, Michigan | — | $99 |
Investigators on these documents
FEI number 3009631819 · most recent document Dec 21, 2023
About Neogen Corporation
How many FDA Form 483s has Neogen Corporation received?
FDA Intel has 2 Form 483s on file for Neogen Corporation; the most recent is dated Dec 21, 2023.
When was Neogen Corporation last inspected by FDA?
The most recent FDA inspection document on file for Neogen Corporation is a Form 483 dated Dec 21, 2023, for the site in Lexington, Kentucky.
What did FDA cite at Neogen Corporation?
The regulations cited most in the observations on file for Neogen Corporation are 21 CFR 211.122(d) (Materials examination and usage criteria), 2 times; 21 CFR 211.113(a) (Control of microbiological contamination), 1 time; 21 CFR 211.142(b) (Warehousing procedures), 1 time.
Has Neogen Corporation received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Neogen Corporation; the most recent is dated Jan 26, 2016.