FDA Inspection 1263483 — SOADCO, S.L.
The FDA completed an inspection of SOADCO, S.L. on March 7, 2025 in Escaldes Engordany. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 7, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Escaldes Engordany (Andorra)
Citations
| ID | CFR | Description |
|---|---|---|
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |