FDA Inspection 1205843 — FONA S.R.L.
The FDA completed an inspection of FONA S.R.L. on May 19, 2023 in Assago. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- May 19, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Radiation Control and Health Safety Act
- Location
- Assago (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3262 | 21 CFR 820.250(a) | Statistical techniques - Lack of or inadequate procedures |
| 3285 | 21 CFR 820.90(b)(2) | Product rework procedures, Lack of or inadequate procedures |
| 5034 | 21 CFR 1010.2(c) | Certification not based on adequate test/testing program |
| 5910 | 21 CFR 1020.30(h)(1)(ii) | Maintenance schedule (all x-ray eqpt) |