FDA Inspection
Soring Medical TechnologySoring Medical Technology – FDA Inspection, Dec 2, 2011
Record Details
This FDA Inspection record concerns Soring Medical Technology, with an inspection on December 2, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Soring Medical Technology
- Inspection Date
- December 2, 2011
- Product Type
- Devices
View Company Profile
ID · a23d9e23-49ff-46a2-8e1d-974c38e5734b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 756329
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.198(a)Complaints
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.25(a)Personnel
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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