Atlas

Form 483

Teva Pharmaceuticals USA, Inc Form 483, 2010-12-02

FDA issued a Form 483 to Teva Pharmaceuticals USA, Inc on 2010-12-02 with 2 public-safe observations.

483· Form 483 issued2 observations

Teva Pharmaceuticals USA, Inc · Parsippany, United States · Issued December 2, 2010

Overview

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

Inspectional observations

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

2 Dec 2010
21 CFR 211.192

Written record of investigation incomplete

Cited by Gayle S Lawson

2 Dec 2010
21 CFR 314.81(b)(1)(ii)

Failure to meet specifications

Cited by Gayle S Lawson

Inspected site

TPTeva Pharmaceuticals USA, IncParsippany, United States

Inspection team

GSGayle S Lawson

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 314.81(b)(1)(ii)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