FDA Inspection
Bluewave Technologies IncBluewave Technologies Inc – FDA Inspection, May 22, 2026
Record Details
This FDA Inspection record concerns Bluewave Technologies Inc, with an inspection on May 22, 2026, issued by the Center for Devices and Radiological Health, covering devices.
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ID · d8999740-b0b3-43ea-a10b-567f4d6b8b9e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1319022
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 830Devices subject to device identification GUDID data submission requirements.
- 21 CFR 801.20(a)Label to bear a unique device identifier
- ISO 13485:2016 Clause 4.2.4Lack of document control
- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
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