FDA Inspection
Mercedes Medical, Inc.Mercedes Medical, Inc. – FDA Inspection, Jul 9, 2009
Record Details
This FDA Inspection record concerns Mercedes Medical, Inc., with an inspection on July 9, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Mercedes Medical, Inc.
- Inspection Date
- July 9, 2009
- Product Type
- Devices
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ID · c1facd11-90c2-4b25-9fa3-7204ac647c8f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 595700
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
12- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.20(a)Management ensuring quality policy is understood
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.50(b)Approval, inadequate purchasing data
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.198(e)Maintained
Showing 10 of 12 citations.
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Other FDA inspections of Mercedes Medical, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 20, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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