FDA Inspection
M Dialysis ABM Dialysis AB – FDA Inspection, Nov 9, 2017
Record Details
This FDA Inspection record concerns M Dialysis AB, with an inspection on November 9, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 66cb2919-2630-4f55-9b24-876a9b17c72a
Inspection Facts
- Inspection number
- 1031381
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50(a)(2)Supplier oversight
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.90(a)Nonconforming product control
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Other FDA inspections of M Dialysis AB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| March 13, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for M Dialysis AB
- FDA Inspection 872452 - 2014-03-13
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