FDA Inspection
BioElectronics CorporationBioElectronics Corporation – FDA Inspection, Jul 10, 2026
Record Details
This FDA Inspection record concerns BioElectronics Corporation, with an inspection on July 10, 2026, issued by the Baltimore District Office, covering medical devices & rad health.
- Company
- BioElectronics Corporation
- Inspection Date
- July 10, 2026
- Product Type
- Medical Devices & Rad Health
- Person
View Company Profile
ID · 39fe88b0-e07c-48a2-bd64-586a2a86ca62
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1328376
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
- ISO 13485:2016 Clause 7.3.9Procedures to control design and development changes not documented
- ISO 13485:2016 Clause 7.4.3Purchased product verification activities not established or implemented
- ISO 13485:2016 Clause 7.5.1Production and service provision not adequate
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures not documented
- ISO 13485:2016 Clause 8.3.1Procedure for nonconforming product not documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of BioElectronics Corporation
3| Date | Classification | Office | Project area |
|---|---|---|---|
| January 16, 2020 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 14, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 28, 2009 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for BioElectronics Corporation
- FDA Inspection 1123763 - 2020-01-16
- FDA Inspection 934351 - 2015-07-14
- FDA Inspection 576907 - 2009-04-28
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.