FDA Inspection
Biowave CorporationBiowave Corporation – FDA Inspection, Jul 28, 2010
Record Details
This FDA Inspection record concerns Biowave Corporation, with an inspection on July 28, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Biowave Corporation
- Inspection Date
- July 28, 2010
- Product Type
- Devices
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ID · e4a2edf7-6c36-4eab-a189-2f9c871c394d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 675465
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.198(b)Rationale documented for no investigation
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Other FDA inspections of Biowave Corporation
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 26, 2026 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 21, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 27, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 28, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 18, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Biowave Corporation
- FDA Inspection 1319378 - 2026-05-26
- FDA Inspection 1208686 - 2023-06-21
- FDA Inspection 1009909 - 2017-04-27
- FDA Inspection 846625 - 2013-08-28
- FDA Inspection 711692 - 2011-02-18
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