FDA Inspection
FMI MEDISCH BVFMI MEDISCH BV – FDA Inspection, May 15, 2025
Record Details
This FDA Inspection record concerns FMI MEDISCH BV, with an inspection on May 15, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 52021ae7-8413-4ad2-988b-599515a296ef
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1270231
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
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Other FDA inspections of FMI MEDISCH BV
2| Date | Classification | Office | Project area |
|---|---|---|---|
| February 9, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 21, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for FMI MEDISCH BV
- FDA Inspection 1200087 - 2023-02-09
- FDA Inspection 1009657 - 2017-04-21
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