FDA Inspection
Terumo BCT, Inc.Terumo BCT, Inc. – FDA Inspection, Jun 23, 2009
Record Details
This FDA Inspection record concerns Terumo BCT, Inc., with an inspection on June 23, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Terumo BCT, Inc.
- Inspection Date
- June 23, 2009
- Product Type
- Devices
View Company Profile
ID · 7f06c64e-bb7a-4f5e-9930-35fd31284388
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 592441
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.70(a)(2)Production monitoring and control
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Terumo BCT, Inc.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| August 25, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 20, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 5, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 28, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 1, 2010 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Terumo BCT, Inc.
- FDA Inspection 1023093 - 2017-08-25
- FDA Inspection 879493 - 2014-05-20
- FDA Inspection 811247 - 2012-12-05
- FDA Inspection 751672 - 2011-10-28
- FDA Inspection 696956 - 2010-11-01
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