Atlas

Form 483

Ultrasound Medical Devices, Inc. Form 483, 2015-04-03

FDA issued a Form 483 to Ultrasound Medical Devices, Inc. on 2015-04-03 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Ultrasound Medical Devices, Inc. · Ann Arbor, United States · Issued April 3, 2015

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

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

3 Apr 2015
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Cynthia L Aycock, Cynthia Li

3 Apr 2015
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Cynthia L Aycock, Cynthia Li

Inspected site

UMUltrasound Medical Devices, Inc.Ann Arbor, United States

Inspection team

CLCynthia L Aycock
CLCynthia Li

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.198(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