FDA Inspection
3Shape Poland3Shape Poland – FDA Inspection, Jun 30, 2017
Record Details
This FDA Inspection record concerns 3Shape Poland, with an inspection on June 30, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- People
- Donna L. Besone (Issuing Officer)
- Jocelyn E. Massey (Issuing Officer)
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ID · 5e6f5b58-2e9c-4d07-80f9-985f280f372d
Inspection Facts
- Inspection number
- 1016400
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.184DHR content
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training records
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of 3Shape Poland
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 26, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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