FDA Inspection
Terumo Medical CorporationTerumo Medical Corporation – FDA Inspection, Jan 13, 2017
Record Details
This FDA Inspection record concerns Terumo Medical Corporation, with an inspection on January 13, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Marc S. Neubauer (Issuing Officer)
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ID · 9a2c1384-ab67-43d2-8e01-8c3414dafafd
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1003680
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.30(d)Design output - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.90(a)Nonconforming product control
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Terumo Medical Corporation
8| Date | Classification | Office | Project area |
|---|---|---|---|
| September 11, 2026 | Not classified | Baltimore District Office | Compliance: Devices |
| May 1, 2026 | Not classified | Baltimore District Office | |
| October 28, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 20, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 23, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Terumo Medical Corporation
- FDA Inspection 1332082 - 2026-09-11
- FDA Inspection 1317212 - 2026-05-01
- FDA Inspection 1182280 - 2022-10-28
- FDA Inspection 1094113 - 2019-06-20
- FDA Inspection 950051 - 2015-10-23
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