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Form 483

Abbott Molecular, Inc. Form 483, 2023-01-27

FDA issued a Form 483 to Abbott Molecular, Inc. on 2023-01-27 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Abbott Molecular, Inc. · Des Plaines, United States · Issued January 27, 2023

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

27 Jan 2023
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Jesse A Vazquez

27 Jan 2023
21 CFR 820.100(b)

Documentation

Cited by Jesse A Vazquez

Inspected site

AMAbbott Molecular, Inc.Des Plaines, United States

Inspection team

JAJesse A Vazquez

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.100(b)Cited across public-safe Form 483 observations1x

Source document

PDF
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Form 483 source document

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Full 483 report

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The source PDF, 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