FDA Inspection 803541 — Spes Medica Srl
The FDA completed an inspection of Spes Medica Srl on Oct 4, 2012 in Battipaglia. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 7 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Oct 4, 2012
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Battipaglia (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3226 | 21 CFR 820.70(g)(1) | Maintenance schedule, Lack of or inadequate schedule |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |