Company
United StatesOralDNA Labs, Inc. A Quest Diagnostics Company, Brentwood, TN – FDA Inspections
Inspection records and compliance data for OralDNA Labs, Inc. A Quest Diagnostics Company in Brentwood, Tennessee. 2 FDA inspections on record (1 OAI), last inspected September 17, 2012.
Company Profile
This profile covers OralDNA Labs, Inc. A Quest Diagnostics Company based in Brentwood, Tennessee, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 1
- VAI
- 0
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected November 23, 2011. Last inspected September 17, 2012.
Most cited issue areas
- Lack of or inadequate complaint procedures1 inspection
- Lack of or inadequate procedures1 inspection
- Lack of or inadequate procedures - Acceptance activities1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 17, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 800074 |
| November 23, 2011 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 754408 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
OralDNA Labs, Inc. A Quest Diagnostics Company
FEI Number
3008381789
Address
214 Overlook Cir Ste 120, Brentwood, Tennessee 37027, United States
Country
United States
ID: 1fbbd5b8-bc05-460f-b4e9-0598dba7678d