FDA Inspection
Premium Dental, LLCPremium Dental, LLC – FDA Inspection, Aug 5, 2009
Record Details
This FDA Inspection record concerns Premium Dental, LLC, with an inspection on August 5, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Premium Dental, LLC
- Inspection Date
- August 5, 2009
- Product Type
- Devices
View Company Profile
ID · 570a6003-9bf0-447a-a52f-a1a412d76378
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 602129
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.198(a)General
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Premium Dental, LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| December 13, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Premium Dental, LLC
- FDA Inspection 706410 - 2010-12-13
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