Atlas

Form 483

RAUMEDIC - MUENCHBERG Form 483, 2015-01-29

FDA issued a Form 483 to RAUMEDIC - MUENCHBERG on 2015-01-29 with 4 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health4 observations

RAUMEDIC - MUENCHBERG · Helmbrechts, Germany · Issued January 29, 2015

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

29 Jan 2015
21 CFR 803.17(a)(1)

Lack of System for Event Evaluations

Cited by Catherine J Laufmann

29 Jan 2015
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Catherine J Laufmann

29 Jan 2015
21 CFR 820.30(f)

Design verification - documentation

Cited by Catherine J Laufmann

29 Jan 2015
21 CFR 820.30(g)

Design validation - documentation

Cited by Catherine J Laufmann

Inspected site

R-RAUMEDIC - MUENCHBERGHelmbrechts, Germany

Inspection team

CJCatherine J Laufmann

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.17(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x
21 CFR 820.30(f)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 4 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