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Form 483

Imaging Biometrics LLC Form 483, 2013-03-22

FDA issued a Form 483 to Imaging Biometrics LLC on 2013-03-22 with 4 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health4 observations

Imaging Biometrics LLC · Elm Grove, United States · Issued March 22, 2013

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.

22 Mar 2013
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Melissa J Holz

22 Mar 2013
21 CFR 806.20(b)(4)

Justification for not reporting

Cited by Melissa J Holz

22 Mar 2013
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Melissa J Holz

22 Mar 2013
21 CFR 820.198(e)

Records of complaint investigation

Cited by Melissa J Holz

Inspected site

IBImaging Biometrics LLCElm Grove, United States

Inspection team

MJMelissa J Holz

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.17Cited across public-safe Form 483 observations1x
21 CFR 806.20(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x
21 CFR 820.198(e)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