Atlas

Form 483

Medion Grifols Diagnostics AG Form 483, 2011-08-11

FDA issued a Form 483 to Medion Grifols Diagnostics AG on 2011-08-11 with 1 public-safe observation.

483· Form 483 issued1 observation

Medion Grifols Diagnostics AG · Dudingen, Switzerland · Issued August 11, 2011

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.

11 Aug 2011
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Frank J Marciniak

Inspected site

MGMedion Grifols Diagnostics AGDudingen, Switzerland

Inspection team

FJFrank J Marciniak

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(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