FDA Inspection
OralDNA Labs, Inc. A Quest Diagnostics CompanyOralDNA Labs, Inc. A Quest Diagnostics Company – FDA Inspection, Nov 23, 2011
Record Details
This FDA Inspection record concerns OralDNA Labs, Inc. A Quest Diagnostics Company, with an inspection on November 23, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 23, 2011
- Product Type
- Devices
View Company Profile
ID · 560e5f54-ff88-48b3-b447-a684bb875b20
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 754408
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 820.198(b)Review and evaluation for investigation
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of OralDNA Labs, Inc. A Quest Diagnostics Company
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 17, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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