FDA Inspection 821533 — DeRoyal Cientifica De Latinoamerica S.R.L.
The FDA completed an inspection of DeRoyal Cientifica De Latinoamerica S.R.L. on Feb 28, 2013 in Heredia. 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
- Feb 28, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Heredia (Costa Rica)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 2269 | 21 CFR 820.20(a) | Quality policy and objectives |
| 2339 | 21 CFR 820.22 | Quality Audit/Reaudit - documentation |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |
| 649 | 21 CFR 803.18(e) | Info not obtained or submitted |