FDA Inspection
Advanced Surgical Design & Manufacture, Ltd.Advanced Surgical Design & Manufacture, Ltd. – FDA Inspection, Sep 22, 2011
Record Details
This FDA Inspection record concerns Advanced Surgical Design & Manufacture, Ltd., with an inspection on September 22, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- September 22, 2011
- Product Type
- Devices
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ID · c31b4c8d-a079-4be7-8706-bee52bc243b8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 749929
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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