FDA Inspection
Synovo ProductionSynovo Production – FDA Inspection, Oct 26, 2022
Record Details
This FDA Inspection record concerns Synovo Production, with an inspection on October 26, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Synovo Production
- Inspection Date
- October 26, 2022
- Product Type
- Devices
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ID · a95306b1-a21c-4860-8bba-3734329ddd3d
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1182099
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.25(b)Training records
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 820.20(c)Management review dates
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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 2, 2023 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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