FDA Inspection
Bionica Inc.Bionica Inc. – FDA Inspection, Jun 9, 2017
Record Details
This FDA Inspection record concerns Bionica Inc., with an inspection on June 9, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c810ca41-5bf8-4a6e-907c-7e704a59f252
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1013534
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design validation - Risk analysis
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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Other FDA inspections of Bionica Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 16, 2018 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 14, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 3, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Bionica Inc.
- FDA Inspection 1061626 - 2018-07-16
- FDA Inspection 901734 - 2014-10-14
- FDA Inspection 633383 - 2009-12-03
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