Company
NetherlandsFMI MEDISCH BV, Schiedam, Netherlands – FDA Inspections
Inspection records and compliance data for FMI MEDISCH BV in Schiedam. 3 FDA inspections on record, 2 Form 483s, last inspected May 15, 2025.
Company Profile
This profile covers FMI MEDISCH BV based in Schiedam, Netherlands.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 2
- NAI
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected April 21, 2017. Last inspected May 15, 2025.
Most cited issue areas
- Documentation1 inspection
- Lack/Inad procedure-Monitoring/Control of Validated Proces1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 15, 2025 | VAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1270231 |
| February 9, 2023 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1200087 |
| April 21, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1009657 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
FMI MEDISCH BV
FEI Number
3010370500
Address
De Brauwweg 17, Schiedam, Netherlands
Country
Netherlands
ID: b22cbac8-4340-4b6f-9c9c-88ea0b454589