Atlas

Form 483

Wellington Laboratories Inc. Form 483, 2012-07-19

FDA issued a Form 483 to Wellington Laboratories Inc. on 2012-07-19 with 3 public-safe observations.

483· Form 483 issued3 observations

Wellington Laboratories Inc. · Guelph, Canada · Issued July 19, 2012

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.

19 Jul 2012
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Sony Mathews

19 Jul 2012
21 CFR 211.165(e)

Test methods

Cited by Sony Mathews

19 Jul 2012
21 CFR 211.194(a)(8)

Second person sign off

Cited by Sony Mathews

Inspected site

WLWellington Laboratories Inc.Guelph, Canada

Inspection team

SMSony Mathews

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.165(e)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(8)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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