FDA Inspection
Synovo ProductionSynovo Production – FDA Inspection, Oct 2, 2023
Record Details
This FDA Inspection record concerns Synovo Production, with an inspection on October 2, 2023, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 7940e37a-4fb5-4ef6-8756-68944bede375
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1219420
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.25(b)Training records
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.25(b)Training records
- 21 CFR 820.30(j)Design history file
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
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Other FDA inspections of Synovo Production
2| Date | Classification | Office | Project area |
|---|---|---|---|
| June 12, 2025 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 26, 2022 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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