FDA Inspection
DRG International, Inc.DRG International, Inc. – FDA Inspection, Nov 26, 2014
Record Details
This FDA Inspection record concerns DRG International, Inc., with an inspection on November 26, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- DRG International, Inc.
- Inspection Date
- November 26, 2014
- Product Type
- Devices
View Company Profile
ID · 2ec37867-1dde-4512-8cb5-b190b07ccb6f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 906885
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.100(b)Documentation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
Full citation text and observation details available on the Dashboard.
Other FDA inspections of DRG International, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| April 15, 2019 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 11, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 15, 2009 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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