FDA Inspection
Healgen Scientific LLCHealgen Scientific LLC – FDA Inspection, Mar 22, 2018
Record Details
This FDA Inspection record concerns Healgen Scientific LLC, with an inspection on March 22, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a7fc7ced-766c-426d-b7b6-8feca13433e2
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1045915
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: 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 Healgen Scientific LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 25, 2014 | VAI | Center for Devices and Radiological Health | Compliance: 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 887242 - 2014-06-25
- FDA Inspection 724997 - 2011-05-18
- FDA Inspection 651057 - 2010-03-25
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