FDA Inspection 1119327 — DiAgam Societe Anonyme (S.A.)
The FDA completed an inspection of DiAgam Societe Anonyme (S.A.) on Feb 20, 2020 in Ath. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 6 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 20, 2020
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Ath (Belgium)
Citations
| ID | CFR | Description |
|---|---|---|
| 3102 | 21 CFR 820.30(h) | Design transfer - Lack of or inadequate procedures |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |
| 3310 | 21 CFR 820.120(b) | DHR documentation of label release {see also 820.184} |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |