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Form 483

Barr Laboratories, Inc. (subsidiary of Teva Pharmaceuticals) Form 483, 2013-05-17

FDA issued a Form 483 to Barr Laboratories, Inc. (subsidiary of Teva Pharmaceuticals) on 2013-05-17 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Barr Laboratories, Inc. (subsidiary of Teva Pharmaceuticals) · Pomona, United States · Issued May 17, 2013

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.

17 May 2013
21 CFR 211.67(b)

Written procedures not established/followed

Cited by Paul C Mouris

17 May 2013
21 CFR 211.111

Establishment of time limitations

Cited by Paul C Mouris

Inspected site

BLBarr Laboratories, Inc. (subsidiary of Teva Pharmaceuticals)Pomona, United States

Inspection team

PCPaul C Mouris

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.111Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x

Source document

PDF
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Form 483 source document

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Full 483 report

Get the verbatim text of all 2 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