FDA Inspection
Biowave CorporationBiowave Corporation – FDA Inspection, Apr 27, 2017
Record Details
This FDA Inspection record concerns Biowave Corporation, with an inspection on April 27, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 858ab6c4-9e77-4868-a5fc-3b5be8ca2bf7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1009909
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
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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 |
| 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 |
| July 28, 2010 | VAI | 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 846625 - 2013-08-28
- FDA Inspection 711692 - 2011-02-18
- FDA Inspection 675465 - 2010-07-28
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