FDA Inspection
Bionx Medical Technologies, Inc.Bionx Medical Technologies, Inc. – FDA Inspection, Oct 13, 2011
Record Details
This FDA Inspection record concerns Bionx Medical Technologies, Inc., with an inspection on October 13, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- October 13, 2011
- Product Type
- Devices
View Company Profile
ID · bcda5324-1123-4972-8514-fe4e72955233
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 749293
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.75(a)Documentation
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.70(g)Equipment Installation, Placement, Specified Requirements
- 21 CFR 820.30(f)Design verification - documentation
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Other FDA inspections of Bionx Medical Technologies, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 25, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Bionx Medical Technologies, Inc.
- FDA Inspection 871457 - 2014-03-25
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