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Form 483

Vertex Pharmaceuticals Incorporated Form 483, 2014-10-16

FDA issued a Form 483 to Vertex Pharmaceuticals Incorporated on 2014-10-16 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Vertex Pharmaceuticals Incorporated · Boston, United States · Issued October 16, 2014

Overview

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

16 Oct 2014
21 CFR 211.192

Investigations of discrepancies, failures

Cited by Camerson E Moore

16 Oct 2014
21 CFR 314.80(b)

Failure to develop written procedures

Cited by Camerson E Moore

16 Oct 2014
21 CFR 314.80(c)(1)(i)

Late submission of 15-day report

Cited by Camerson E Moore

Inspected site

VPVertex Pharmaceuticals IncorporatedBoston, United States

Inspection team

CECamerson E Moore

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 314.80(b)Cited across public-safe Form 483 observations1x
21 CFR 314.80(c)(1)(i)Cited 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