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Form 483

Puma Biotechnology, Inc. Form 483, 2019-05-24

FDA issued a Form 483 to Puma Biotechnology, Inc. on 2019-05-24 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Puma Biotechnology, Inc. · Los Angeles, United States · Issued May 24, 2019

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

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

24 May 2019
21 CFR 312.50

General responsibilities of sponsors

Cited by Angela Shepas, Ni A Khin, Yangmin Ning

Inspected site

PBPuma Biotechnology, Inc.Los Angeles, United States

Inspection team

ASAngela Shepas
NANi A Khin
YNYangmin Ning

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 312.50Cited across public-safe Form 483 observations1x

Source document

PDF
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Form 483 source document

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Full 483 report

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  • 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