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Form 483

Richard Wolf Medical Instruments Corp. Form 483, 2012-09-10

FDA issued a Form 483 to Richard Wolf Medical Instruments Corp. on 2012-09-10 with 1 public-safe observation.

483· Form 483 issued1 observation

Richard Wolf Medical Instruments Corp. · Vernon Hills, United States · Issued September 10, 2012

Overview

  • 1 public-safe observation is 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.

10 Sep 2012
21 CFR 820.184

DHR - not or inadequately maintained

Cited by Joseph A Morkunas

Inspected site

RWRichard Wolf Medical Instruments Corp.Vernon Hills, United States

Inspection team

JAJoseph A Morkunas

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.184Cited across public-safe Form 483 observations1x

Source document

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Form 483 source document

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  • 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