Atlas

Form 483

Confab Laboratories Inc. Form 483, 2013-06-07

FDA issued a Form 483 to Confab Laboratories Inc. on 2013-06-07 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Confab Laboratories Inc. · Saint-Hubert, Canada · Issued June 7, 2013

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

7 Jun 2013
21 CFR 211.192

Extent of discrepancy, failure investigations

Cited by Christopher D Leach

Inspected site

CLConfab Laboratories Inc.Saint-Hubert, Canada

Inspection team

CDChristopher D Leach

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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