Atlas

Form 483

Medart A /S Form 483, 2018-05-31

FDA issued a Form 483 to Medart A /S on 2018-05-31 with 9 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health9 observations

Medart A /S · Hvidovre, Denmark · Issued May 31, 2018

Overview

  • 9 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.

31 May 2018
21 CFR 1002.10

Failure to submit, distinct marking

Cited by Kathleen S Tormey

31 May 2018
21 CFR 1002.10

Failure to submit, distinct marking

Cited by Kathleen S Tormey

31 May 2018
21 CFR 1002.10

Failure to submit, distinct marking

Cited by Kathleen S Tormey

31 May 2018
21 CFR 1010.2(b)

Certification label or tag

Cited by Kathleen S Tormey

31 May 2018
21 CFR 1010.2(b)

Certification label or tag

Cited by Kathleen S Tormey

Inspected site

MAMedart A /SHvidovre, Denmark

Inspection team

KSKathleen S Tormey

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1002.10Cited across public-safe Form 483 observations3x
21 CFR 1010.2(b)Cited across public-safe Form 483 observations3x
21 CFR 820.50Cited across public-safe Form 483 observations3x

Full 483 report

Get the verbatim text of all 9 observations

The full inspection record, as Atlas holds it, 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