FDA Inspection
Healgen Scientific LLCHealgen Scientific LLC – FDA Inspection, Jun 13, 2019
Record Details
This FDA Inspection record concerns Healgen Scientific LLC, with an inspection on June 13, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f3d30d95-e464-41e4-8a28-b86d66cc4384
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1093192
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Healgen Scientific LLC
4| Date | Classification | Office | Project area |
|---|---|---|---|
| December 8, 2025 | NAI | Compliance: Devices | |
| October 15, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 1, 2013 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 23, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Healgen Scientific LLC
- FDA Inspection 1296424 - 2025-12-08
- FDA Inspection 945550 - 2015-10-15
- FDA Inspection 820050 - 2013-03-01
- FDA Inspection 701533 - 2010-12-23
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