FDA Inspection
DS REP B.V.DS REP B.V. – FDA Inspection, Mar 23, 2018
Record Details
This FDA Inspection record concerns DS REP B.V., with an inspection on March 23, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 4a2e584d-fbb1-4841-a099-05226caa7652
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1046784
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.198(c)Investigation of device failures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of DS REP B.V.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| October 17, 2025 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 16, 2022 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 6, 2013 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| March 18, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for DS REP B.V.
- FDA Inspection 1288064 - 2025-10-17
- FDA Inspection 1173360 - 2022-06-16
- FDA Inspection 821728 - 2013-03-06
- FDA Inspection 652360 - 2010-03-18
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