FDA Inspection
Terumo Cardiovascular Systems CorporationTerumo Cardiovascular Systems Corporation – FDA Inspection, Mar 29, 2010
Record Details
This FDA Inspection record concerns Terumo Cardiovascular Systems Corporation, with an inspection on March 29, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- March 29, 2010
- Product Type
- Devices
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ID · e3a78e80-6211-458e-8157-a28df0ce3bca
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 636280
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
15- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 803.52(b)(5)Description of the Event or Problem
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 803.56Submission of Supplement to Individual Report Within One Month
- 21 CFR 820.100(a)(2)Investigation
- 21 CFR 820.198(a)General
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)(1)Statistical methodology
- 21 CFR 820.100(a)(4)CAPA verification/validation of corrective/preventive action
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Other FDA inspections of Terumo Cardiovascular Systems Corporation
9| Date | Classification | Office | Project area |
|---|---|---|---|
| July 14, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 11, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 3, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 7, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 13, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Terumo Cardiovascular Systems Corporation
- FDA Inspection 1147794 - 2021-07-14
- FDA Inspection 1111814 - 2019-10-11
- FDA Inspection 1031879 - 2017-10-03
- FDA Inspection 996655 - 2016-12-07
- FDA Inspection 971672 - 2016-05-13
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