Form 483

DRG Instruments GmbH Form 483, 2019-10-31

FDA issued a Form 483 to DRG Instruments GmbH on 2019-10-31 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

DRG Instruments GmbH · Marburg, Germany · Issued October 31, 2019

Overview

  • 3 public-safe observations are available for this inspection.
  • 1 structured CFR citation is 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 Oct 2019
21 CFR 820.100(b)

Documentation

Cited by Eric C Fox

31 Oct 2019
21 CFR 820.100(b)

Documentation

Cited by Eric C Fox

31 Oct 2019
21 CFR 820.100(b)

Documentation

Cited by Eric C Fox

Inspected site

DIDRG Instruments GmbHMarburg, Germany

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(b)Cited across public-safe Form 483 observations3x

Full 483 report

Get the verbatim text of all 3 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