FDA Inspection
BioSerenity USA, Inc.BioSerenity USA, Inc. – FDA Inspection, Sep 6, 2016
Record Details
This FDA Inspection record concerns BioSerenity USA, Inc., with an inspection on September 6, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- BioSerenity USA, Inc.
- Inspection Date
- September 6, 2016
- Product Type
- Devices
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ID · 450493f6-97df-4870-8b3d-f923984372d1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 985197
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
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Other FDA inspections of BioSerenity USA, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 5, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| January 5, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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