FDA Inspection
Rite-dent Manufacturing Corp.Rite-dent Manufacturing Corp. – FDA Inspection, Jul 8, 2010
Record Details
This FDA Inspection record concerns Rite-dent Manufacturing Corp., with an inspection on July 8, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- July 8, 2010
- Product Type
- Devices
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ID · 366ab175-ff89-43d3-87bb-ba1048639553
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 670603
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
22- 21 CFR 820.80(e)Documentation
- 21 CFR 820.30(g)Design validation acceptance criteria
- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.72(a)Equipment control activity documentation
- 21 CFR 820.20(a)Management ensuring quality policy is understood
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.25(b)Training records
- 21 CFR 820.100(a)Lack of or inadequate procedures
Showing 10 of 22 citations.
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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 |
| November 16, 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 698163 - 2010-11-16
- FDA Inspection 654426 - 2010-03-23
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