Form 483

Discus Dental LLC Form 483, 2019-10-17

FDA issued a Form 483 to Discus Dental LLC on 2019-10-17 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Discus Dental LLC · Ontario, United States · Issued October 17, 2019

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

17 Oct 2019
21 CFR 211.165(b)

Microbiological testing

Cited by Marcus F Yambot, Diane R Weidley

Inspected site

DDDiscus Dental LLCOntario, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.165(b)Cited across public-safe Form 483 observations1x

Source document

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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