FDA Inspection
Dexcowin Global Inc.Dexcowin Global Inc. – FDA Inspection, Jul 24, 2015
Record Details
This FDA Inspection record concerns Dexcowin Global Inc., with an inspection on July 24, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Dexcowin Global Inc.
- Inspection Date
- July 24, 2015
- Product Type
- Devices
View Company Profile
ID · ab73cf44-6657-428a-a3f2-b2f6ed9c9ffd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 934629
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 803.18(d)(1)Distributor responsibilities for complaint records
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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