FDA Inspection
Prime Herbs CorporationPrime Herbs Corporation – FDA Inspection, Apr 1, 2016
Record Details
This FDA Inspection record concerns Prime Herbs Corporation, with an inspection on April 1, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Prime Herbs Corporation
- Inspection Date
- April 1, 2016
- Product Type
- Devices
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ID · ede5c19c-5574-41cf-b872-bad88b9ed08a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 975323
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Prime Herbs Corporation
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 17, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 6, 2013 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 14, 2012 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Prime Herbs Corporation
- FDA Inspection 941138 - 2015-09-17
- FDA Inspection 855059 - 2013-11-06
- FDA Inspection 794658 - 2012-08-14
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