FDA Inspection
3Shape A/S3Shape A/S – FDA Inspection, Feb 9, 2012
Record Details
This FDA Inspection record concerns 3Shape A/S, with an inspection on February 9, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- 3Shape A/S
- Inspection Date
- February 9, 2012
- Product Type
- Devices
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ID · a8a5c363-e10c-4361-a42d-8ffe4b7058b8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 769413
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.30(h)Incorrect translation to production specifications
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