FDA Inspection
KCI POLYMEDICS BVKCI POLYMEDICS BV – FDA Inspection, Dec 11, 2025
Record Details
This FDA Inspection record concerns KCI POLYMEDICS BV, with an inspection on December 11, 2025, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · c0be04c8-a98c-4c24-a9b7-d441242077ee
Inspection Facts
- Inspection number
- 1295806
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
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Other FDA inspections of KCI POLYMEDICS BV
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 26, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 28, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for KCI POLYMEDICS BV
- FDA Inspection 1198000 - 2023-01-26
- FDA Inspection 699362 - 2010-10-28
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