Form 483

Vertex Pharmaceuticals Incorporated Form 483, 2016-09-21

FDA issued a Form 483 to Vertex Pharmaceuticals Incorporated on 2016-09-21 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Vertex Pharmaceuticals Incorporated · Boston, United States · Issued September 21, 2016

Overview

2 public-safe observations are available for this inspection.
2 structured CFR citations are represented.
4 investigators are tied to this Form 483.

Inspectional observations

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

21 Sep 2016

21 CFR 211.25(a)

Training , Education , Experience overall

Cited by Edmund F Mrak, Sean R Marcsisin, Vioela J Caze, Kenneth H Williams

21 Sep 2016

21 CFR 211.84(d)(2)

Establish reliability of supplier's C of A

Cited by Edmund F Mrak, Sean R Marcsisin, Vioela J Caze, Kenneth H Williams

Inspected site

VPVertex Pharmaceuticals IncorporatedBoston, United States

Inspection team

EFEdmund F Mrak

SRSean R Marcsisin

VJVioela J Caze

KHKenneth H Williams

Cited regulations

CFR citations associated with this Form 483.

Citation	What it covers	Cited
21 CFR 211.25(a)	Cited across public-safe Form 483 observations	1x
21 CFR 211.84(d)(2)	Cited across public-safe Form 483 observations	1x

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