FDA Inspection
De Soutter Medical LtdDe Soutter Medical Ltd – FDA Inspection, Apr 26, 2018
Record Details
This FDA Inspection record concerns De Soutter Medical Ltd, with an inspection on April 26, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 162610ed-e183-4eba-8a4f-a141fea33616
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1050506
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.90(a)Nonconforming product control
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
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Other FDA inspections of De Soutter Medical Ltd
1| Date | Classification | Office | Project area |
|---|---|---|---|
| February 2, 2023 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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