Biowave Corporation – FDA Inspection, Jun 21, 2023

Record Details

This FDA Inspection record concerns Biowave Corporation, with an inspection on June 21, 2023, issued by the Center for Devices and Radiological Health, covering devices.

Company: Biowave Corporation
Inspection Date: June 21, 2023
Product Type: Devices
Office: Center for Devices and Radiological Health
Person: Katarzyna Plona

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ID · 8a11b592-40ba-4ba1-a179-139431a759db

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 1208686
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 820.198(a)Lack of or inadequate complaint procedures
21 CFR 820.20(c)Management review - defined interval, sufficient frequency
21 CFR 820.22Quality Audit/Reaudit - conducted
21 CFR 820.50Purchasing controls, Lack of or inadequate procedures

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Other FDA inspections of Biowave Corporation

Date	Classification	Office	Project area
May 26, 2026	VAI	Center for Devices and Radiological Health	Postmarket Assurance: 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