FDA Inspection
Tosoh Bioscience IncTosoh Bioscience Inc – FDA Inspection, Oct 16, 2018
Record Details
This FDA Inspection record concerns Tosoh Bioscience Inc, with an inspection on October 16, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · aa4285b1-d28f-4d4f-a386-871fb5dd2fed
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1068847
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Tosoh Bioscience Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 11, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 28, 2016 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 17, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 5, 2010 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 27, 2010 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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