Atlas

Form 483

Elanco UK AH Limited Form 483, 2015-06-25

FDA issued a Form 483 to Elanco UK AH Limited on 2015-06-25 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Elanco UK AH Limited · Liverpool, United Kingdom · Issued June 25, 2015

Overview

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

Inspectional observations

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

25 Jun 2015
21 CFR 211.84(d)(2)

Establish reliability of supplier's C of A

Cited by Torrance J Slayton

25 Jun 2015
21 CFR 211.84(d)(2)

Establish reliability of supplier's C of A

Cited by Torrance J Slayton

Inspected site

EUElanco UK AH LimitedLiverpool, United Kingdom

Inspection team

TJTorrance J Slayton

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 2 observations

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