FDA Inspection 793444 — Contract Medical International Spol. Sr.O.
The FDA completed an inspection of Contract Medical International Spol. Sr.O. on Aug 9, 2012 in Hradec Kralove 3. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 2 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Aug 9, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Hradec Kralove 3 (Czech Republic)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |