Atlas

Form 483

G f P S - Gesellschaft fr Produktionshygiene und Sterilittssicherung mbH Form 483, 2011-06-21

FDA issued a Form 483 to G f P S - Gesellschaft fr Produktionshygiene und Sterilittssicherung mbH on 2011-06-21 with 2 public-safe observations.

483· Form 483 issued2 observations

G f P S - Gesellschaft fr Produktionshygiene und Sterilittssicherung mbH · Aachen, Germany · Issued June 21, 2011

Overview

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

Inspectional observations

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

21 Jun 2011
21 CFR 211.160(a)

Lab controls established, including changes

Cited by Binh T Nguyen, Maria A Reed

21 Jun 2011
21 CFR 211.194(a)(4)

Complete Test Data

Cited by Binh T Nguyen, Maria A Reed

Inspected site

GFG f P S - Gesellschaft fr Produktionshygiene und Sterilittssicherung mbHAachen, Germany

Inspection team

BTBinh T Nguyen
MAMaria A Reed

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(a)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(4)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 observations

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