FDA Inspection
Terumo BCT, Inc.Terumo BCT, Inc. – FDA Inspection, Nov 1, 2010
Record Details
This FDA Inspection record concerns Terumo BCT, Inc., with an inspection on November 1, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Terumo BCT, Inc.
- Inspection Date
- November 1, 2010
- Product Type
- Devices
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ID · be45bb89-632f-490f-ae5f-e4f1bccc95c3
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 696956
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
12- 21 CFR 820.80(e)Documentation
- 21 CFR 803.52(a)(1)Patient Name or Other Identifier
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 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 820.25(b)Training records
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
Showing 10 of 12 citations.
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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 |
| June 23, 2009 | VAI | 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 592441 - 2009-06-23
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