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Form 483

Medion Grifols Diagnostics AG Form 483, 2015-07-30

FDA issued a Form 483 to Medion Grifols Diagnostics AG on 2015-07-30 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

Medion Grifols Diagnostics AG · Dudingen, Switzerland · Issued July 30, 2015

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.

30 Jul 2015
21 CFR 820.70(c)

Environmental control Lack of or inadequate procedures

Cited by Jonathan B Lewis

Inspected site

MGMedion Grifols Diagnostics AGDudingen, Switzerland

Inspection team

JBJonathan B Lewis

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.70(c)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