FDA Inspection
Hart Technologies, Inc.Hart Technologies, Inc. – FDA Inspection, Oct 14, 2025
Record Details
This FDA Inspection record concerns Hart Technologies, Inc., with an inspection on October 14, 2025, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · c8a0c30a-22d7-48d3-94bf-53f0a7d6f41d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1287024
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 801.20(a)Label to bear a unique device identifier
- 21 CFR 820.100(a)Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Hart Technologies, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 17, 2008 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Hart Technologies, Inc.
- FDA Inspection 555082 - 2008-12-17
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.