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Form 483

Vanguard EMS, Inc. Form 483, 2019-06-05

FDA issued a Form 483 to Vanguard EMS, Inc. on 2019-06-05 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

Vanguard EMS, Inc. · Beaverton, United States · Issued June 5, 2019

Overview

  • 3 public-safe observations are 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.

5 Jun 2019
21 CFR 820.72(b)

Remedial action

Cited by James W Whitney

5 Jun 2019
21 CFR 820.72(b)

Remedial action

Cited by James W Whitney

5 Jun 2019
21 CFR 820.72(b)

Remedial action

Cited by James W Whitney

Inspected site

VEVanguard EMS, Inc.Beaverton, United States

Inspection team

JWJames W Whitney

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.72(b)Cited across public-safe Form 483 observations3x

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 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