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Form 483

Corcept Therapeutics Incorporated Form 483, 2014-05-09

FDA issued a Form 483 to Corcept Therapeutics Incorporated on 2014-05-09 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Corcept Therapeutics Incorporated · Redwood City, United States · Issued May 9, 2014

Overview

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

Inspectional observations

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

9 May 2014
21 CFR 314.80(b)

Failure to develop written procedures

Cited by Anh Lac

Inspected site

CTCorcept Therapeutics IncorporatedRedwood City, United States

Inspection team

ALAnh Lac

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 314.80(b)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

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Full 483 report

Get the verbatim text of all 1 observation

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