Company
United StatesQuest Medical, Inc., Allen, TX – FDA Inspections
Inspection records and compliance data for Quest Medical, Inc. in Allen, Texas. 2 FDA inspections on record, last inspected August 22, 2014.
Company Profile
This profile covers Quest Medical, Inc. based in Allen, Texas, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected August 27, 2010. Last inspected August 22, 2014.
Most cited issue areas
- Design validation- Lack of or inadequate procedures1 inspection
- Investigation of device failures1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 22, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 892147 |
| August 27, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 678385 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Quest Medical, Inc.
FEI Number
3001665800
Address
1 Allentown Pkwy, Allen, Texas 75002, United States
Country
United States
ID: e6a0ecac-fe93-4b36-92d2-c19663a030d3