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Form 483

Richard Wolf Medical Instruments Corp. Form 483, 2020-03-18

FDA issued a Form 483 to Richard Wolf Medical Instruments Corp. on 2020-03-18 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Richard Wolf Medical Instruments Corp. · Vernon Hills, United States · Issued March 18, 2020

Overview

  • 2 public-safe observations are available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

18 Mar 2020
21 CFR 803.50(a)(2)

Individual Report of Malfunction

Cited by Nicholas Z Lu

18 Mar 2020
21 CFR 803.50(a)(2)

Individual Report of Malfunction

Cited by Nicholas Z Lu

Inspected site

RWRichard Wolf Medical Instruments Corp.Vernon Hills, United States

Inspection team

NZNicholas Z Lu

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.50(a)(2)Cited across public-safe Form 483 observations2x

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