FDA Inspection
Quest Medical, Inc.Quest Medical, Inc. – FDA Inspection, Aug 27, 2010
Record Details
This FDA Inspection record concerns Quest Medical, Inc., with an inspection on August 27, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Quest Medical, Inc.
- Inspection Date
- August 27, 2010
- Product Type
- Devices
View Company Profile
ID · 9d280cb6-64d9-49e7-8865-c26c4cb9a939
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 678385
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.198(d)Records of MDR Investigation
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product control
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Other FDA inspections of Quest Medical, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 22, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Quest Medical, Inc.
- FDA Inspection 892147 - 2014-08-22
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