FDA Inspection
Mercedes Medical, Inc.Mercedes Medical, Inc. – FDA Inspection, Aug 20, 2010
Record Details
This FDA Inspection record concerns Mercedes Medical, Inc., with an inspection on August 20, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Mercedes Medical, Inc.
- Inspection Date
- August 20, 2010
- Product Type
- Devices
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ID · eae15e06-b0fc-4f85-aa62-0d6b5d77e9c4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 676190
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
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Other FDA inspections of Mercedes Medical, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| July 9, 2009 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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