FDA-Inspected Site

RAUMEDIC - MUENCHBERG

3 FDA inspections are on record for RAUMEDIC - MUENCHBERG in Helmbrechts, Germany.

483· Form 483 issued

Helmbrechts, Germany · Last updated July 9, 2026

Overview

  • 3 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2023-02-02.

At a glance

Inspections

3

Form 483s

3

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
30 Jan 2023 – 2 Feb 2023Medical Devices & Rad Health483View 483 →
30 Oct 2017 – 2 Nov 2017Medical Devices & Rad Health483View 483 →
26 Jan 2015 – 29 Jan 2015Medical Devices & Rad Health483View 483 →

Observations on record

Form 483 observations cited at this site, most recent first.

2 Feb 2023
21 CFR 803.50(a)(2)

Individual Report of Malfunction

Cited by Miaja Umaedi

2 Nov 2017
21 CFR 820.30(g)

Design validation - Risk analysis

Cited by Kimberly Lewandowski-Walker

2 Nov 2017
21 CFR 820.30(g)

Design validation - Risk analysis

Cited by Kimberly Lewandowski-Walker

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

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.30(g)Cited across public-safe Form 483 observations3x
21 CFR 803.17(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 803.50(a)(2)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

Full site report

Get the verbatim findings behind RAUMEDIC - MUENCHBERG's 3 Form 483s

Verbatim observations and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat