FDA Inspection
DS REP B.V.DS REP B.V. – FDA Inspection, Mar 6, 2013
Record Details
This FDA Inspection record concerns DS REP B.V., with an inspection on March 6, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- DS REP B.V.
- Inspection Date
- March 6, 2013
- Product Type
- Devices
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ID · 4f95d7a2-180d-488d-9a04-798955c61d3e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 821728
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
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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 23, 2018 | VAI | Center for Devices and Radiological Health | Compliance: 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 1046784 - 2018-03-23
- FDA Inspection 652360 - 2010-03-18
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