Form 483

Terumo Corporation Form 483, 2016-02-05

FDA issued a Form 483 to Terumo Corporation on 2016-02-05 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

Terumo Corporation · Nakakoma-Gun, Japan · Issued February 5, 2016

Overview

3 public-safe observations are available for this inspection.
3 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.

5 Feb 2016

21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Stephen D Eich

5 Feb 2016

21 CFR 820.80(d)

Lack of or inadequate final acceptance procedures

Cited by Stephen D Eich

5 Feb 2016

21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Stephen D Eich

Inspected site

TCTerumo CorporationNakakoma-Gun, Japan

Inspection team

SDStephen D Eich

Cited regulations

CFR citations associated with this Form 483.

Citation	What it covers	Cited
21 CFR 820.100(a)	Cited across public-safe Form 483 observations	1x
21 CFR 820.75(a)	Cited across public-safe Form 483 observations	1x
21 CFR 820.80(d)	Cited across public-safe Form 483 observations	1x

Full 483 report

Get the verbatim text of all 3 observations

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