Form 483

Neogen Corporation Form 483, 2026-03-06

FDA issued a Form 483 to Neogen Corporation on 2026-03-06 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

Neogen Corporation · Lexington, United States · Issued March 6, 2026

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

6 Mar 2026
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Martin M Kimani

6 Mar 2026
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Martin M Kimani

6 Mar 2026
21 CFR 211.84(d)(1)

Component identity verification

Cited by Martin M Kimani

6 Mar 2026
21 CFR 211.84(d)(2)

Establish reliability of supplier's C of A

Cited by Martin M Kimani

Inspected site

NCNeogen CorporationLexington, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 observations

The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere