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Form 483

Abbott Molecular, Inc. Form 483, 2014-07-11

FDA issued a Form 483 to Abbott Molecular, Inc. on 2014-07-11 with 4 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health4 observations

Abbott Molecular, Inc. · Des Plaines, United States · Issued July 11, 2014

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

11 Jul 2014
21 CFR 806.10(a)(1)

Report of risk to health

Cited by Paola S Barnett

11 Jul 2014
21 CFR 820.70(a)

Production processes

Cited by Paola S Barnett

11 Jul 2014
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Paola S Barnett

11 Jul 2014
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Paola S Barnett

Inspected site

AMAbbott Molecular, Inc.Des Plaines, United States

Inspection team

PSPaola S Barnett

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 806.10(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x
21 CFR 820.70(a)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 4 observations

The source PDF and 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