FDA Inspection
Healgen Scientific LLCHealgen Scientific LLC – FDA Inspection, Jun 25, 2014
Record Details
This FDA Inspection record concerns Healgen Scientific LLC, with an inspection on June 25, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Healgen Scientific LLC
- Inspection Date
- June 25, 2014
- Product Type
- Devices
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ID · 34d0939d-aa96-4704-a927-298d6b37ef4a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 887242
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
1- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Healgen Scientific LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 22, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 18, 2011 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 25, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Healgen Scientific LLC
- FDA Inspection 1045915 - 2018-03-22
- FDA Inspection 724997 - 2011-05-18
- FDA Inspection 651057 - 2010-03-25
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