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Form 483

3DPX Medical Form 483, 2022-07-28

FDA issued a Form 483 to 3DPX Medical on 2022-07-28 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

3DPX Medical · Chicago, United States · Issued July 28, 2022

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

28 Jul 2022
21 CFR 820.40

Procedures not adequately established or maintained

Cited by Brittani N Franklin

28 Jul 2022
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Brittani N Franklin

28 Jul 2022
21 CFR 820.80(c)

Documentation

Cited by Brittani N Franklin

Inspected site

3M3DPX MedicalChicago, United States

Inspection team

BNBrittani N Franklin

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.40Cited across public-safe Form 483 observations1x
21 CFR 820.75(a)Cited across public-safe Form 483 observations1x
21 CFR 820.80(c)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

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Full 483 report

Get the verbatim text of all 3 observations

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