Atlas

Form 483

Takeda Ireland Limited Form 483, 2018-04-27

FDA issued a Form 483 to Takeda Ireland Limited on 2018-04-27 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

Takeda Ireland Limited · Kilruddery, Ireland · Issued April 27, 2018

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.

27 Apr 2018
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by William J Leonard

27 Apr 2018
21 CFR 211.194(a)(2)

Suitability of testing methods verified

Cited by William J Leonard

27 Apr 2018
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by William J Leonard

27 Apr 2018
21 CFR 211.68(a)

Calibration/Inspection/Checking not done

Cited by William J Leonard

Inspected site

TITakeda Ireland LimitedKilruddery, Ireland

Inspection team

WJWilliam J Leonard

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 211.194(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.68(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