FDA Inspection
Hemagen Diagnostics IncHemagen Diagnostics Inc – FDA Inspection, May 14, 2026
Record Details
This FDA Inspection record concerns Hemagen Diagnostics Inc, with an inspection on May 14, 2026, issued by the Center for Devices and Radiological Health, covering medical devices & rad health.
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ID · 93b62636-b780-4484-82a8-1062f5f511f3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1317040
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- ISO 13485:2016 Clause 7.1Supplier performance not monitored
- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
- ISO 13485:2016 Clause 4.2.5Procedures for control of records not documented
- ISO 13485:2016 Clause 8.5.2Corrective action not taken
- ISO 13485:2016 Clause 7.4.1Supplier performance not monitored
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Hemagen Diagnostics Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| June 14, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 10, 2018 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 10, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 20, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 25, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Hemagen Diagnostics Inc
- FDA Inspection 1208393 - 2023-06-14
- FDA Inspection 1037233 - 2018-01-10
- FDA Inspection 918077 - 2015-03-10
- FDA Inspection 812190 - 2012-12-20
- FDA Inspection 677299 - 2010-08-25
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