Company
NetherlandsSYNERGIE NEDERLAND BV, Raamsdonksveer, Netherlands – FDA Inspections
Inspection records and compliance data for SYNERGIE NEDERLAND BV in Raamsdonksveer. 1 FDA inspection on record, 1 Form 483, last inspected September 10, 2026.
Company Profile
This profile covers SYNERGIE NEDERLAND BV based in Raamsdonksveer, Netherlands.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 0
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
Inspected September 10, 2026.
Most cited issue areas
- Complaint handling records not maintained1 inspection
- Design and development file does not include or reference required records1 inspection
- Internal audits not conducted to ensure QMS meets requirements and is effective1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 10, 2026 | Not classified | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1338226 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
SYNERGIE NEDERLAND BV
FEI Number
3018070887
Address
Sterrekroos 6, Raamsdonksveer, Netherlands
Country
Netherlands
ID: 344f7151-42d1-46ce-af9f-d8399e43ddd5