Form 483

Diversey Canada, Inc Form 483, 2016-04-22

FDA issued a Form 483 to Diversey Canada, Inc on 2016-04-22 with 18 public-safe observations.

483· Form 483 issuedHuman Drugs18 observations

Diversey Canada, Inc · London, Canada · Issued April 22, 2016

Overview

  • 18 public-safe observations are available for this inspection.
  • 9 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.

22 Apr 2016
21 CFR 211.122(g)

Failure to include one of special control procedures

Cited by Christopher D Leach

22 Apr 2016
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Christopher D Leach

22 Apr 2016
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Christopher D Leach

22 Apr 2016
21 CFR 211.170(b)

Drug product reserve containers

Cited by Christopher D Leach

22 Apr 2016
21 CFR 211.170(b)

Drug product reserve containers

Cited by Christopher D Leach

Inspected site

DCDiversey Canada, IncLondon, Canada

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.122(g)Cited across public-safe Form 483 observations2x
21 CFR 211.160(b)Cited across public-safe Form 483 observations2x
21 CFR 211.166(a)(2)Cited across public-safe Form 483 observations2x
21 CFR 211.166(a)(3)Cited across public-safe Form 483 observations2x
21 CFR 211.170(b)Cited across public-safe Form 483 observations2x
21 CFR 211.192Cited across public-safe Form 483 observations2x
21 CFR 211.196Cited across public-safe Form 483 observations2x
21 CFR 211.198(a)Cited across public-safe Form 483 observations2x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 18 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