Company
CanadaHart Technologies, Inc., Markham, Canada – FDA Inspections
Inspection records and compliance data for Hart Technologies, Inc. in Markham. 2 FDA inspections on record, last inspected October 14, 2025.
Company Profile
This profile covers Hart Technologies, Inc. based in Markham, Canada.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected December 17, 2008. Last inspected October 14, 2025.
Most cited issue areas
- Design control - no procedures1 inspection
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Devices subject to device identification GUDID data submission requirements.1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 14, 2025 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1287024 |
| December 17, 2008 | NAI | Medical Devices & Rad Health · Compliance: Devices | 555082 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Hart Technologies, Inc.
FEI Number
3004204440
Address
161 Don Park Road, Markham, Canada
Country
Canada
ID: bb2d2b47-74d2-46f6-a60a-b5737e582950