FDA Inspection
Samhall ABSamhall AB – FDA Inspection, Jun 15, 2017
Record Details
This FDA Inspection record concerns Samhall AB, with an inspection on June 15, 2017, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 69168055-ed0d-483e-8267-d4c1a007495c
Inspection Facts
- Inspection number
- 1014755
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training records
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Samhall AB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 9, 2023 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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