Form 483

Vanguard EMS, Inc. Form 483, 2015-12-04

FDA issued a Form 483 to Vanguard EMS, Inc. on 2015-12-04 with 10 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health10 observations

Vanguard EMS, Inc. · Beaverton, United States · Issued December 4, 2015

Overview

  • 10 public-safe observations are available for this inspection.
  • 5 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.

4 Dec 2015
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Stanley B Eugene

4 Dec 2015
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Stanley B Eugene

4 Dec 2015
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Stanley B Eugene

4 Dec 2015
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Stanley B Eugene

4 Dec 2015
21 CFR 820.40

Procedures not adequately established or maintained

Cited by Stanley B Eugene

Inspected site

VEVanguard EMS, Inc.Beaverton, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations2x
21 CFR 820.198(a)Cited across public-safe Form 483 observations2x
21 CFR 820.40Cited across public-safe Form 483 observations2x
21 CFR 820.70(b)Cited across public-safe Form 483 observations2x
21 CFR 820.72(a)Cited across public-safe Form 483 observations2x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 10 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