FDA Inspection
Magnificent Medical Equipment, Inc. DBA Tony Riso CompanyMagnificent Medical Equipment, Inc. DBA Tony Riso Company – FDA Inspection, Nov 19, 2009
Record Details
This FDA Inspection record concerns Magnificent Medical Equipment, Inc. DBA Tony Riso Company, with an inspection on November 19, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- November 19, 2009
- Product Type
- Devices
View Company Profile
ID · 826268ef-9800-4f2a-9c56-13defdc5966e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 629716
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
14- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.198(a)General
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.80(b)Incoming inspection, testing, verification
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.198(e)(6)Results of investigation
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