FDA Inspection
FMI MEDISCH BVFMI MEDISCH BV – FDA Inspection, Apr 21, 2017
Record Details
This FDA Inspection record concerns FMI MEDISCH BV, with an inspection on April 21, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 4a0bac41-f0af-4099-b5e5-2e8b4126294f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1009657
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.80(e)Documentation
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.90(b)(2)Product rework adverse effects {see also 820.184}
- 21 CFR 820.72(b)Remedial action - documentation
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.250(b)Sampling plans
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Other FDA inspections of FMI MEDISCH BV
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 15, 2025 | VAI | Office of Inspections and Investigations | Compliance: Medical Devices |
| February 9, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for FMI MEDISCH BV
- FDA Inspection 1270231 - 2025-05-15
- FDA Inspection 1200087 - 2023-02-09
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