FDA Inspection
Sequana Medical NVSequana Medical NV – FDA Inspection, Apr 25, 2024
Record Details
This FDA Inspection record concerns Sequana Medical NV, with an inspection on April 25, 2024, issued by the Center for Devices and Radiological Health.
- Company
- Sequana Medical NV
- Inspection Date
- April 25, 2024
View Company Profile
ID · 87a0718b-8d64-4f74-a420-e629e854bbe2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1237847
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
FDA Citations
4- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
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