FDA Inspection
Prime Herbs CorporationPrime Herbs Corporation – FDA Inspection, Aug 14, 2012
Record Details
This FDA Inspection record concerns Prime Herbs Corporation, with an inspection on August 14, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Prime Herbs Corporation
- Inspection Date
- August 14, 2012
- Product Type
- Devices
View Company Profile
ID · 96619f46-4fe1-4ed9-b255-72a186c4679f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 794658
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
16- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.130Packaging
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.160(a)Lack of or inadequate procedures for distribution
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
Showing 10 of 16 citations.
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Other FDA inspections of Prime Herbs Corporation
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 1, 2016 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| September 17, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 6, 2013 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Prime Herbs Corporation
- FDA Inspection 975323 - 2016-04-01
- FDA Inspection 941138 - 2015-09-17
- FDA Inspection 855059 - 2013-11-06
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