1117348
Laboratorios Dentales De Zona Franca, S.A. — FEI 3001295407
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 30, 2020
- Fiscal Year
- 2020
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- San Isidro Del Guarco (Costa Rica)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3266 | 21 CFR 820.86 | Acceptance status |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |