FDA Inspection
Healgen Scientific LLCHealgen Scientific LLC – FDA Inspection, Dec 23, 2010
Record Details
This FDA Inspection record concerns Healgen Scientific LLC, with an inspection on December 23, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Healgen Scientific LLC
- Inspection Date
- December 23, 2010
- Product Type
- Devices
View Company Profile
ID · 5299db7f-78fd-4054-811e-5e1f673ebfe6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 701533
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 820.80(e)Documentation
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.80(c)Lack of or inadequate In-process acceptance procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control 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 | |
| June 13, 2019 | VAI | Center for Devices and Radiological Health | 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 |
Other documents for Healgen Scientific LLC
- FDA Inspection 1296424 - 2025-12-08
- FDA Inspection 1093192 - 2019-06-13
- FDA Inspection 945550 - 2015-10-15
- FDA Inspection 820050 - 2013-03-01
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