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Form 483

Ultrasound Medical Devices, Inc. Form 483, 2018-05-23

FDA issued a Form 483 to Ultrasound Medical Devices, Inc. on 2018-05-23 with 8 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health8 observations

Ultrasound Medical Devices, Inc. · Ann Arbor, United States · Issued May 23, 2018

Overview

  • 8 public-safe observations are available for this inspection.
  • 4 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.

23 May 2018
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Amy S Graf

23 May 2018
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Amy S Graf

23 May 2018
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Amy S Graf

23 May 2018
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Amy S Graf

23 May 2018
21 CFR 820.180

Availability

Cited by Amy S Graf

Inspected site

UMUltrasound Medical Devices, Inc.Ann Arbor, United States

Inspection team

ASAmy S Graf

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 820.180Cited across public-safe Form 483 observations2x
21 CFR 820.198(a)Cited across public-safe Form 483 observations2x
21 CFR 820.25(b)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.

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Full 483 report

Get the verbatim text of all 8 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