FDA Inspection
Mdsysco LLCMdsysco LLC – FDA Inspection, Mar 25, 2011
Record Details
This FDA Inspection record concerns Mdsysco LLC, with an inspection on March 25, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Mdsysco LLC
- Inspection Date
- March 25, 2011
- Product Type
- Devices
View Company Profile
ID · 4fa3677e-50a1-4f8d-9242-eae346ea2e90
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 719826
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of Mdsysco LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 10, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Mdsysco LLC
- FDA Inspection 888037 - 2014-07-10
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