FDA Inspection
Hemedex, Inc.Hemedex, Inc. – FDA Inspection, Oct 5, 2017
Record Details
This FDA Inspection record concerns Hemedex, Inc., with an inspection on October 5, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e42fbca6-8e08-49c5-b65a-0e034fefbc47
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1028218
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Hemedex, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 19, 2026 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 17, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 1333962 - 2026-08-19
- FDA Inspection 1207959 - 2023-02-17
- FDA Inspection 822744 - 2013-03-14
- FDA Inspection 667620 - 2010-06-10
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