Company
United StatesBioElectronics Corporation, Frederick, MD – FDA Inspections
Inspection records and compliance data for BioElectronics Corporation in Frederick, Maryland. 4 FDA inspections on record, 1 Form 483, 1 warning letter, last inspected July 10, 2026.
Company Profile
This profile covers BioElectronics Corporation based in Frederick, Maryland, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 3
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 1
First inspected April 28, 2009. Last inspected July 10, 2026.
Most cited issue areas
- Complaint handling procedures not documented1 inspection
- Procedure for nonconforming product not documented1 inspection
- Procedures to control design and development changes not documented1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 10, 2026 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1328376 |
| January 16, 2020 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1123763 |
| July 14, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 934351 |
| April 28, 2009 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 576907 |
FDA documents
Warning Letters (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
BioElectronics Corporation
FEI Number
3005550216
Address
4539 Metropolitan Ct, Frederick, Maryland 21704, United States
Country
United States
ID: ebbf1432-07a9-484e-b8d6-a1051bbf15ca