FDA Inspection
3SHAPE TRIOS A/S3SHAPE TRIOS A/S – FDA Inspection, Jun 30, 2017
Record Details
This FDA Inspection record concerns 3SHAPE TRIOS A/S, with an inspection on June 30, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Donna L. Besone (Issuing Officer)
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ID · 13abd976-4a9c-4c9b-8eae-8d67f0c87a47
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1016399
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.30(b)Design plans- updated
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation - production units
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