Atlas

Form 483

Medart A /S Form 483, 2013-09-13

FDA issued a Form 483 to Medart A /S on 2013-09-13 with 5 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health5 observations

Medart A /S · Hvidovre, Denmark · Issued September 13, 2013

Overview

  • 5 public-safe observations are available for this inspection.
  • 5 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.

13 Sep 2013
21 CFR 803.56

Submission Within One Month

Cited by Amy M Cramer

13 Sep 2013
21 CFR 820.30(e)

Design review procedures - personnel

Cited by Amy M Cramer

13 Sep 2013
21 CFR 820.50(b)

Supplier notification of changes

Cited by Amy M Cramer

13 Sep 2013
21 CFR 1002.10

Failure to submit, distinct marking

Cited by Amy M Cramer

13 Sep 2013
21 CFR 1040.10(g)(5)(i)

Aperture label - laser radiation

Cited by Amy M Cramer

Inspected site

MAMedart A /SHvidovre, Denmark

Inspection team

AMAmy M Cramer

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1002.10Cited across public-safe Form 483 observations1x
21 CFR 1040.10(g)(5)(i)Cited across public-safe Form 483 observations1x
21 CFR 803.56Cited across public-safe Form 483 observations1x
21 CFR 820.30(e)Cited across public-safe Form 483 observations1x
21 CFR 820.50(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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