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Form 483

Novartis Pharma Stein AG Form 483, 2018-12-04

FDA issued a Form 483 to Novartis Pharma Stein AG on 2018-12-04 with 3 public-safe observations.

483· Form 483 issuedBiologics3 observations

Novartis Pharma Stein AG · Stein Ag, Switzerland · Issued December 4, 2018

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

4 Dec 2018
21 CFR 211.42(c)(10)(iv)

Environmental Monitoring System

Cited by Travis S Bradley, Mihaly S Ligmond

4 Dec 2018
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Travis S Bradley, Mihaly S Ligmond

4 Dec 2018
21 CFR 211.58

Buildings not maintained in good state of repair

Cited by Travis S Bradley, Mihaly S Ligmond

Inspected site

NPNovartis Pharma Stein AGStein Ag, Switzerland

Inspection team

TSTravis S Bradley
MSMihaly S Ligmond

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(iv)Cited across public-safe Form 483 observations1x
21 CFR 211.58Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 3 observations

The source PDF and 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