FDA Inspection
Hemedex, Inc.Hemedex, Inc. – FDA Inspection, Aug 19, 2026
Record Details
This FDA Inspection record concerns Hemedex, Inc., with an inspection on August 19, 2026, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Hemedex, Inc.
- Inspection Date
- August 19, 2026
- Product Type
- Devices
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ID · 49e044fe-98c4-4fa7-acd5-2700b654aea2
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1333962
- Project area
- Postmarket Assurance: Devices
FDA Citations
3- ISO 13485:2016 Clause 7.1Records of risk management activities in product realization not maintained
- ISO 13485:2016 Clause 7.3.10Design and development validation not performed as planned
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures not documented
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Other FDA inspections of Hemedex, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 17, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 5, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 14, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 10, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Hemedex, Inc.
- FDA Inspection 1207959 - 2023-02-17
- FDA Inspection 1028218 - 2017-10-05
- FDA Inspection 822744 - 2013-03-14
- FDA Inspection 667620 - 2010-06-10
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