Atlas

Form 483

Novartis Pharma Stein AG Form 483, 2010-07-02

FDA issued a Form 483 to Novartis Pharma Stein AG on 2010-07-02 with 2 public-safe observations.

483· Form 483 issued2 observations

Novartis Pharma Stein AG · Stein Ag, Switzerland · Issued July 2, 2010

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.

2 Jul 2010
21 CFR 211.68(a)

Calibration/Inspection/Checking not done

Cited by Michele L Obert, Vlada Matusovsky

2 Jul 2010
21 CFR 606.100(c)

Thorough investigations

Cited by Michele L Obert, Vlada Matusovsky

Inspected site

NPNovartis Pharma Stein AGStein Ag, Switzerland

Inspection team

MLMichele L Obert
VMVlada Matusovsky

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.68(a)Cited across public-safe Form 483 observations1x
21 CFR 606.100(c)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