FDA Inspection 839097 — SEDECAL SA
The FDA completed an inspection of SEDECAL SA on June 28, 2013 in Algete. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- June 28, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Algete (Spain)
Citations
| ID | CFR | Description |
|---|---|---|
| 3118 | 21 CFR 820.75(a) | Documentation |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |