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Form 483

3T Medical Systems, LLC Form 483, 2012-02-17

FDA issued a Form 483 to 3T Medical Systems, LLC on 2012-02-17 with 4 public-safe observations.

483· Form 483 issued4 observations

3T Medical Systems, LLC · Livonia, United States · Issued February 17, 2012

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.

17 Feb 2012
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Thomas A Peter

17 Feb 2012
21 CFR 820.120

Lack of or inadequate procedures for labeling

Cited by Thomas A Peter

17 Feb 2012
21 CFR 820.184

Lack of or inadequate DHR procedures

Cited by Thomas A Peter

17 Feb 2012
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Thomas A Peter

Inspected site

3M3T Medical Systems, LLCLivonia, United States

Inspection team

TAThomas A Peter

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.17Cited across public-safe Form 483 observations1x
21 CFR 820.120Cited across public-safe Form 483 observations1x
21 CFR 820.184Cited across public-safe Form 483 observations1x
21 CFR 820.198(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