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Form 483

Olympus Medical Systems Corporation Form 483, 2022-09-09

FDA issued a Form 483 to Olympus Medical Systems Corporation on 2022-09-09 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

Olympus Medical Systems Corporation · Hachioji, Japan · Issued September 9, 2022

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.

9 Sep 2022
21 CFR 803.50(a)(1)

Report of Death or Serious Injury

Cited by Esteban Beltran

Inspected site

OMOlympus Medical Systems CorporationHachioji, Japan

Inspection team

EBEsteban Beltran

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.50(a)(1)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 1 observation

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