FDA Inspection
Terumo Medical CorporationTerumo Medical Corporation – FDA Inspection, Jun 20, 2019
Record Details
This FDA Inspection record concerns Terumo Medical Corporation, with an inspection on June 20, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 64690c93-12b4-40b1-833d-882ddc9f0d1b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1094113
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.20(e)Quality System Procedures
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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 |
| 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 1332082 - 2026-09-11
- FDA Inspection 1317212 - 2026-05-01
- FDA Inspection 1182280 - 2022-10-28
- FDA Inspection 1003680 - 2017-01-13
- FDA Inspection 950051 - 2015-10-23
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