Atlas

Form 483

Abbott Molecular, Inc. Form 483, 2011-05-24

FDA issued a Form 483 to Abbott Molecular, Inc. on 2011-05-24 with 2 public-safe observations.

483· Form 483 issued2 observations

Abbott Molecular, Inc. · Des Plaines, United States · Issued May 24, 2011

Overview

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

Inspectional observations

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

24 May 2011
21 CFR 803.50(a)(1)

Report of Death or Serious Injury

Cited by Christopher D Leach, Nicole S Williams

24 May 2011
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Christopher D Leach, Nicole S Williams

Inspected site

AMAbbott Molecular, Inc.Des Plaines, United States

Inspection team

CDChristopher D Leach
NSNicole S Williams

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.50(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)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