FDA Inspection
Biowave CorporationBiowave Corporation – FDA Inspection, May 26, 2026
Record Details
This FDA Inspection record concerns Biowave Corporation, with an inspection on May 26, 2026, issued by the Center for Devices and Radiological Health, covering medical devices & rad health.
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ID · cb6b1af4-d017-41fe-aadb-a6d142d7a6ae
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1319378
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- ISO 13485:2016 Clause 7.4.3Purchased product verification activities not established or implemented
- ISO 13485:2016 Clause 6.1(a)Resources for quality management system have not been determined or provided
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Biowave Corporation
5| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| July 28, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Biowave Corporation
- FDA Inspection 1208686 - 2023-06-21
- FDA Inspection 1009909 - 2017-04-27
- FDA Inspection 846625 - 2013-08-28
- FDA Inspection 711692 - 2011-02-18
- FDA Inspection 675465 - 2010-07-28
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