Atlas

Form 483

Purdue Pharma Form 483, 2019-04-26

FDA issued a Form 483 to Purdue Pharma on 2019-04-26 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Purdue Pharma · Pickering, Canada · Issued April 26, 2019

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.

26 Apr 2019
21 CFR 211.100(a)

Approval and review of procedures

Cited by Carrie A Hughes

26 Apr 2019
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Carrie A Hughes

Inspected site

PPPurdue PharmaPickering, Canada

Inspection team

CACarrie A Hughes

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x

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