FDA Inspection
Bion Enterprises Ltd.Bion Enterprises Ltd. – FDA Inspection, Nov 18, 2016
Record Details
This FDA Inspection record concerns Bion Enterprises Ltd., with an inspection on November 18, 2016, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e415d848-eae1-4cd4-a76d-b57b31928356
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 993559
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.40(b)Change records, content
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Other FDA inspections of Bion Enterprises Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 18, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 3, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 2, 2009 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Bion Enterprises Ltd.
- FDA Inspection 777732 - 2012-04-18
- FDA Inspection 633746 - 2009-12-03
- FDA Inspection 566149 - 2009-03-02
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