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Form 483

National Dentex LLC Form 483, 2023-03-17

FDA issued a Form 483 to National Dentex LLC on 2023-03-17 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

National Dentex LLC · Fenton, United States · Issued March 17, 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.

17 Mar 2023
21 CFR 820.181

DMR - not or inadequately maintained

Cited by Edward E Lockwood

17 Mar 2023
21 CFR 820.184

Lack of or inadequate DHR procedures

Cited by Edward E Lockwood

Inspected site

NDNational Dentex LLCFenton, United States

Inspection team

EEEdward E Lockwood

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.181Cited across public-safe Form 483 observations1x
21 CFR 820.184Cited 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 2 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