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Form 483

Terumo Corporation Form 483, 2017-02-07

FDA issued a Form 483 to Terumo Corporation on 2017-02-07 with 4 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health4 observations

Terumo Corporation · Fujinomiya, Japan · Issued February 7, 2017

Overview

  • 4 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.

7 Feb 2017
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Angela E Glenn

7 Feb 2017
21 CFR 211.194(a)(4)

Complete Test Data

Cited by Angela E Glenn

7 Feb 2017
21 CFR 211.194(a)(4)

Complete Test Data

Cited by Angela E Glenn

7 Feb 2017
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Angela E Glenn

Inspected site

TCTerumo CorporationFujinomiya, Japan

Inspection team

AEAngela E Glenn

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.194(a)(4)Cited across public-safe Form 483 observations2x
21 CFR 211.22(d)Cited across public-safe Form 483 observations2x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 4 observations

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