Atlas

Form 483

Roche Diagnostics GmbH Form 483, 2016-11-18

FDA issued a Form 483 to Roche Diagnostics GmbH on 2016-11-18 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

Roche Diagnostics GmbH · Mannheim, Germany · Issued November 18, 2016

Overview

  • 1 public-safe observation is 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.

18 Nov 2016
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Richard K Vogel

Inspected site

RDRoche Diagnostics GmbHMannheim, Germany

Inspection team

RKRichard K Vogel

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.75(a)Cited across public-safe Form 483 observations1x

Full 483 report

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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