FDA Inspection
BioElectronics CorporationBioElectronics Corporation – FDA Inspection, Apr 28, 2009
Record Details
This FDA Inspection record concerns BioElectronics Corporation, with an inspection on April 28, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- BioElectronics Corporation
- Inspection Date
- April 28, 2009
- Product Type
- Devices
View Company Profile
ID · e74c1f2b-7ba1-4416-8099-cd16b0a077df
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 576907
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
5- 21 CFR 812.46(a)Sponsor securing investigator compliance
- 21 CFR 812.150(b)(5)Sponsor progress reports for non-significant risk study
- 21 CFR 812.140(b)(4)(ii)Sponsor records re non-significant risk status inadequate
- 21 CFR 812.140(b)(4)(v)Sponsor records re QSR/GMP & non-significant risk studies
- 21 CFR 812.150(b)(2)Sponsor notification of IRB approval withdrawal
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Other FDA inspections of BioElectronics Corporation
3| Date | Classification | Office | Project area |
|---|---|---|---|
| July 10, 2026 | VAI | Baltimore District Office | Compliance: Devices |
| January 16, 2020 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 14, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for BioElectronics Corporation
- FDA Inspection 1328376 - 2026-07-10
- FDA Inspection 1123763 - 2020-01-16
- FDA Inspection 934351 - 2015-07-14
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