FDA Inspection
MediTop BvMediTop Bv – FDA Inspection, Feb 1, 2023
Record Details
This FDA Inspection record concerns MediTop Bv, with an inspection on February 1, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 43603243-3ea1-4162-a72d-b04d0c44e7f7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1196063
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.30(f)Design verification - documentation
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.30(f)Design verification - documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of MediTop Bv
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 10, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for MediTop Bv
- FDA Inspection 943699 - 2015-09-10
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