FDA Inspection
De Soutter Medical LtdDe Soutter Medical Ltd – FDA Inspection, Feb 2, 2023
Record Details
This FDA Inspection record concerns De Soutter Medical Ltd, with an inspection on February 2, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 554c0807-e76c-4233-9093-eb3a4ceac9e0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1196589
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(a)(2)Supplier oversight
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(a)(2)Supplier oversight
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Other FDA inspections of De Soutter Medical Ltd
1| Date | Classification | Office | Project area |
|---|---|---|---|
| April 26, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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