FDA Inspection 748982 — APC Medical, Ltd.
The FDA completed an inspection of APC Medical, Ltd. on September 22, 2011 in Welwyn Garden City. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 22, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Welwyn Garden City (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3347 | 21 CFR 820.200(c) | Service reports/MDRs/complaints |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |