FDA Inspection
Bion Enterprises Ltd.Bion Enterprises Ltd. – FDA Inspection, Mar 2, 2009
Record Details
This FDA Inspection record concerns Bion Enterprises Ltd., with an inspection on March 2, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Bion Enterprises Ltd.
- Inspection Date
- March 2, 2009
- Product Type
- Devices
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ID · 7d4b8ea8-19ec-411f-be89-8596bfbe6f97
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 566149
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.100(a)(2)Investigation
- 21 CFR 820.70(b)Verification or validation of changes
- 21 CFR 820.25(b)Training records
- 21 CFR 820.70(a)Process control procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Bion Enterprises Ltd.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 18, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 18, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 3, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Bion Enterprises Ltd.
- FDA Inspection 993559 - 2016-11-18
- FDA Inspection 777732 - 2012-04-18
- FDA Inspection 633746 - 2009-12-03
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