Atlas

Form 483

Medion Grifols Diagnostics AG Form 483, 2018-12-07

FDA issued a Form 483 to Medion Grifols Diagnostics AG on 2018-12-07 with 3 public-safe observations.

483· Form 483 issuedBiologics3 observations

Medion Grifols Diagnostics AG · Dudingen, Switzerland · Issued December 7, 2018

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 structured CFR citations are represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

7 Dec 2018
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Gene D Arcy, Meihong Liu, Sharmila Shrestha

7 Dec 2018
21 CFR 820.30(g)

Design Validation - Risk analysis not performed/inadequate

Cited by Gene D Arcy, Meihong Liu, Sharmila Shrestha

7 Dec 2018
21 CFR 820.80(a)

Lack of or inadequate procedures - Acceptance activities

Cited by Gene D Arcy, Meihong Liu, Sharmila Shrestha

Inspected site

MGMedion Grifols Diagnostics AGDudingen, Switzerland

Inspection team

GDGene D Arcy
MLMeihong Liu
SSSharmila Shrestha

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.30(g)Cited across public-safe Form 483 observations1x
21 CFR 820.80(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 observations

The full inspection record, as Atlas holds it, 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