Atlas

Form 483

Gold Standard Diagnostics Form 483, 2017-09-13

FDA issued a Form 483 to Gold Standard Diagnostics on 2017-09-13 with 9 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health9 observations

Gold Standard Diagnostics · Davis, United States · Issued September 13, 2017

Overview

  • 9 public-safe observations are available for this inspection.
  • 3 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.

13 Sep 2017
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Mark E Chan

13 Sep 2017
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Mark E Chan

13 Sep 2017
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Mark E Chan

13 Sep 2017
21 CFR 820.40

Procedures not adequately established or maintained

Cited by Mark E Chan

13 Sep 2017
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Mark E Chan

Inspected site

GSGold Standard DiagnosticsDavis, United States

Inspection team

MEMark E Chan

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations3x
21 CFR 820.198(a)Cited across public-safe Form 483 observations3x
21 CFR 820.40Cited across public-safe Form 483 observations3x

Full 483 report

Get the verbatim text of all 9 observations

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