Atlas

Form 483

Myriad Genetics Laboratories, Inc. Form 483, 2014-10-10

FDA issued a Form 483 to Myriad Genetics Laboratories, Inc. on 2014-10-10 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Myriad Genetics Laboratories, Inc. · Salt Lake City, United States · Issued October 10, 2014

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

10 Oct 2014
21 CFR 820.30(g)

Design validation - software validation documentation

Cited by Ashleigh P Wodushek

10 Oct 2014
21 CFR 820.75(a)

Documentation

Cited by Ashleigh P Wodushek

Inspected site

MGMyriad Genetics Laboratories, Inc.Salt Lake City, United States

Inspection team

APAshleigh P Wodushek

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.30(g)Cited across public-safe Form 483 observations1x
21 CFR 820.75(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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