Atlas

Form 483

Ceva Animal Health, LLC Form 483, 2013-02-04

FDA issued a Form 483 to Ceva Animal Health, LLC on 2013-02-04 with 2 public-safe observations.

483· Form 483 issued2 observations

Ceva Animal Health, LLC · Lenexa, United States · Issued February 4, 2013

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

4 Feb 2013
21 CFR 211.198(a)

Complaint Handling Procedure

Cited by Anh Lac

4 Feb 2013
21 CFR 211.198(b)(2)

Complaint Investigation/Follow-Up Findings

Cited by Anh Lac

Inspected site

CACeva Animal Health, LLCLenexa, United States

Inspection team

ALAnh Lac

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x
21 CFR 211.198(b)(2)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.

Book a demoStart a free trial

Full 483 report

Get the verbatim text of all 2 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