Atlas

Form 483

Icare Finland Oy Form 483, 2015-04-22

FDA issued a Form 483 to Icare Finland Oy on 2015-04-22 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

Icare Finland Oy · Espoo, Finland · Issued April 22, 2015

Overview

  • 3 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.

22 Apr 2015
21 CFR 820.100(b)

Documentation

Cited by Ronald Ifraimov

22 Apr 2015
21 CFR 820.20(c)

Management review - defined interval, sufficient frequency

Cited by Ronald Ifraimov

22 Apr 2015
21 CFR 820.30(g)

Design Validation - Risk analysis not performed/inadequate

Cited by Ronald Ifraimov

Inspected site

IFIcare Finland OyEspoo, Finland

Inspection team

RIRonald Ifraimov

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(b)Cited across public-safe Form 483 observations1x
21 CFR 820.20(c)Cited across public-safe Form 483 observations1x
21 CFR 820.30(g)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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