Form 483

Elanco UK AH Limited Form 483, 2013-05-09

FDA issued a Form 483 to Elanco UK AH Limited on 2013-05-09 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

Elanco UK AH Limited · Liverpool, United Kingdom · Issued May 9, 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.

9 May 2013
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Robert C Horan

9 May 2013
21 CFR 211.56(a)

Sanitation--buildings not clean, free of infestation

Cited by Robert C Horan

9 May 2013
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Robert C Horan

9 May 2013
21 CFR 211.166(a)(3)

Valid stability test methods

Cited by Robert C Horan

Inspected site

EUElanco UK AH LimitedLiverpool, United Kingdom

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.56(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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