FDA Inspection
Svar Life Science ABSvar Life Science AB – FDA Inspection, Jan 19, 2017
Record Details
This FDA Inspection record concerns Svar Life Science AB, with an inspection on January 19, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · ba3afce9-7bb2-4e20-9176-09831eab25a2
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1000739
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 803.17(a)(3)Lack of System for Timely Submission of Reports
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Other FDA inspections of Svar Life Science AB
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 26, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Svar Life Science AB
- FDA Inspection 1055353 - 2018-04-26
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