Company
BelgiumKCI POLYMEDICS BV, Peer, Belgium – FDA Inspections
Inspection records and compliance data for KCI POLYMEDICS BV in Peer. 3 FDA inspections on record, 1 Form 483, last inspected December 11, 2025.
Company Profile
This profile covers KCI POLYMEDICS BV based in Peer, Belgium.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 0
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected October 28, 2010. Last inspected December 11, 2025.
Most cited issue areas
- Lack/Inad procedure-Monitoring/Control of Validated Proces1 inspection
- Lack of or inadequate process validation1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 11, 2025 | Not classified | Medical Devices & Rad Health · Compliance: Medical Devices | 1295806 |
| January 26, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1198000 |
| October 28, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 699362 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
KCI POLYMEDICS BV
FEI Number
3003775292
Address
Ambachtslaan 1031, Peer, Belgium
Country
Belgium
ID: 5a747d2e-16ac-4aed-b0da-bf1bc99d5bc4