FDA Inspection
Surgical Concept DesignsSurgical Concept Designs – FDA Inspection, Sep 23, 2011
Record Details
This FDA Inspection record concerns Surgical Concept Designs, with an inspection on September 23, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Surgical Concept Designs
- Inspection Date
- September 23, 2011
- Product Type
- Devices
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ID · 39e6d52f-c25d-4636-86b5-1cbc239cfd4a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 746130
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.200(a)Servicing - Lack of or inadequate procedures
- 21 CFR 820.50(a)(1)Documented evaluation
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