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Form 483

Aspirus Wausau Hospital IRB Form 483, 2019-12-05

FDA issued a Form 483 to Aspirus Wausau Hospital IRB on 2019-12-05 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Aspirus Wausau Hospital IRB · Wausau, United States · Issued December 5, 2019

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.

5 Dec 2019
21 CFR 56.115(a)(2)

Minutes of IRB meetings

Cited by Denise L Burosh

5 Dec 2019
21 CFR 56.115(a)(5)

List of members

Cited by Denise L Burosh

Inspected site

AWAspirus Wausau Hospital IRBWausau, United States

Inspection team

DLDenise L Burosh

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 56.115(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 56.115(a)(5)Cited across public-safe Form 483 observations1x

Source document

PDF
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Form 483 source document

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Full 483 report

Get the verbatim text of all 2 observations

The source PDF, 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