FDA Inspection
Rite-dent Manufacturing Corp.Rite-dent Manufacturing Corp. – FDA Inspection, Nov 16, 2010
Record Details
This FDA Inspection record concerns Rite-dent Manufacturing Corp., with an inspection on November 16, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 16, 2010
- Product Type
- Devices
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ID · 53ef3489-8f03-4259-b522-b1465dc2a726
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 698163
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(a)Production processes
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Other FDA inspections of Rite-dent Manufacturing Corp.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 28, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 8, 2010 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 23, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Rite-dent Manufacturing Corp.
- FDA Inspection 803728 - 2012-08-28
- FDA Inspection 670603 - 2010-07-08
- FDA Inspection 654426 - 2010-03-23
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