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Form 483

Neogen Corporation Form 483, 2013-05-23

FDA issued a Form 483 to Neogen Corporation on 2013-05-23 with 4 public-safe observations.

483· Form 483 issuedAnimal Drugs & Feeds4 observations

Neogen Corporation · Lexington, United States · Issued May 23, 2013

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.

23 May 2013
21 CFR 211.80(a)

Written Procedures Not Followed

Cited by Kathleen D Culver

23 May 2013
21 CFR 211.166(b)

Adequate number of batches on stability

Cited by Kathleen D Culver

23 May 2013
21 CFR 211.180(e)(1)

Review of representative number of batches

Cited by Kathleen D Culver

23 May 2013
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Kathleen D Culver

Inspected site

NCNeogen CorporationLexington, United States

Inspection team

KDKathleen D Culver

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.166(b)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.80(a)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 4 observations

The source PDF and every observation in full, 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