FDA Inspection
Tosoh Bioscience IncTosoh Bioscience Inc – FDA Inspection, Oct 11, 2019
Record Details
This FDA Inspection record concerns Tosoh Bioscience Inc, with an inspection on October 11, 2019, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Tosoh Bioscience Inc
- Inspection Date
- October 11, 2019
- Product Type
- Devices
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ID · 47fc37af-ba0a-4822-bdb4-d34220b60639
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1106186
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
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Other FDA inspections of Tosoh Bioscience Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 16, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: 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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