Atlas

Form 483

Arrotek Medical Ltd Form 483, 2015-07-30

FDA issued a Form 483 to Arrotek Medical Ltd on 2015-07-30 with 6 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health6 observations

Arrotek Medical Ltd · Sligo, Ireland · Issued July 30, 2015

Overview

  • 6 public-safe observations are available for this inspection.
  • 3 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.

30 Jul 2015
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by James M Odonnell

30 Jul 2015
21 CFR 820.80(d)

Lack of or inadequate final acceptance procedures

Cited by James M Odonnell

30 Jul 2015
21 CFR 820.86

Acceptance status

Cited by James M Odonnell

30 Jul 2015
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by James M Odonnell

30 Jul 2015
21 CFR 820.80(d)

Lack of or inadequate final acceptance procedures

Cited by James M Odonnell

Inspected site

AMArrotek Medical LtdSligo, Ireland

Inspection team

JMJames M Odonnell

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.75(a)Cited across public-safe Form 483 observations2x
21 CFR 820.80(d)Cited across public-safe Form 483 observations2x
21 CFR 820.86Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 6 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