FDA Inspection 1295808 — DiAgam Societe Anonyme (S.A.)
The FDA completed an inspection of DiAgam Societe Anonyme (S.A.) on Dec 18, 2025 in Ath. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Dec 18, 2025
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Ath (Belgium)
Citations
| ID | CFR | Description |
|---|---|---|
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3683 | 21 CFR 820.70(g) | Equipment Installation, Placement, Specified Requirements |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |