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Form 483

Terumo Medical Corporation Form 483, 2013-09-12

FDA issued a Form 483 to Terumo Medical Corporation on 2013-09-12 with 1 public-safe observation.

483· Form 483 issuedMedical Devices & Rad Health1 observation

Terumo Medical Corporation · Elkton, United States · Issued September 12, 2013

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.

12 Sep 2013
21 CFR 803.50(a)(2)

Report of Malfunction

Cited by Joseph A Morkunas

Inspected site

TMTerumo Medical CorporationElkton, United States

Inspection team

JAJoseph A Morkunas

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.50(a)(2)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 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