FDA Inspection 1258997 — SEDECAL SA
The FDA completed an inspection of SEDECAL SA on January 24, 2025 in Algete. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 24, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Algete (Spain)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 5034 | 21 CFR 1010.2(c) | Certification not based on adequate test/testing program |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |