FDA Inspection
SYNERGIE NEDERLAND BVSYNERGIE NEDERLAND BV – FDA Inspection, Sep 10, 2026
Record Details
This FDA Inspection record concerns SYNERGIE NEDERLAND BV, with an inspection on September 10, 2026, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Company
- SYNERGIE NEDERLAND BV
- Inspection Date
- September 10, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · ef422e58-ae33-4131-85f1-bdc7cf95d44a
Inspection Facts
- Inspection number
- 1338226
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- ISO 13485:2016 Clause 7.3.10Design and development file does not include or reference required records
- ISO 13485:2016 Clause 7.5.1Medical device or batch records not adequate
- ISO 13485:2016 Clause 8.2.2Complaint handling records not maintained
- ISO 13485:2016 Clause 8.2.4Internal audits not conducted to ensure QMS meets requirements and is effective
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