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Form 483

Ultradent Products, Inc. Form 483, 2017-09-15

FDA issued a Form 483 to Ultradent Products, Inc. on 2017-09-15 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Ultradent Products, Inc. · South Jordan, United States · Issued September 15, 2017

Overview

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

Inspectional observations

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

15 Sep 2017
21 CFR 211.58

Buildings not maintained in good state of repair

Cited by Haroon Vohra

Inspected site

UPUltradent Products, Inc.South Jordan, United States

Inspection team

HVHaroon Vohra

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.58Cited 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 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