FDA Inspection
Terumo Medical CorporationTerumo Medical Corporation – FDA Inspection, Sep 11, 2026
Record Details
This FDA Inspection record concerns Terumo Medical Corporation, with an inspection on September 11, 2026, issued by the Baltimore District Office, covering medical devices & rad health.
- Company
- Terumo Medical Corporation
- Inspection Date
- September 11, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · bb0841ec-3486-4120-bce6-9be752b33b50
Inspection Facts
- Inspection number
- 1332082
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- ISO 13485:2016 Clause 6.3Requirements for infrastructure maintenance activities not documented
- ISO 13485:2016 Clause 6.4.1Work environment requirements and procedures not documented
- ISO 13485:2016 Clause 8.2.2Lack of documented justification for not investigating complaint(s)
- ISO 13485:2016 Clause 8.5.2Corrective action not taken
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Terumo Medical Corporation
8| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| January 13, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 23, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Terumo Medical Corporation
- FDA Inspection 1317212 - 2026-05-01
- FDA Inspection 1182280 - 2022-10-28
- FDA Inspection 1094113 - 2019-06-20
- FDA Inspection 1003680 - 2017-01-13
- FDA Inspection 950051 - 2015-10-23
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