FDA Inspection
Hontech Foundation, LLCHontech Foundation, LLC – FDA Inspection, Oct 23, 2012
Record Details
This FDA Inspection record concerns Hontech Foundation, LLC, with an inspection on October 23, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Hontech Foundation, LLC
- Inspection Date
- October 23, 2012
- Product Type
- Devices
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ID · 1d3436bc-5a76-4940-834d-e151ebe3e149
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 805920
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.50(a)(1)Documented evaluation
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Other FDA inspections of Hontech Foundation, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 25, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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