FDA Inspection 951518 — Bio-Medical Research Ltd
The FDA completed an inspection of Bio-Medical Research Ltd on Nov 5, 2015 in Galway. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 5, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Galway (Ireland)
Citations
| ID | CFR | Description |
|---|---|---|
| 14717 | 21 CFR 820.30(g) | Design validation - software validation documentation |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3173 | 21 CFR 820.198(d) | Evaluation, timeliness, identification |
| 3191 | 21 CFR 820.30(g) | Design validation - production units |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |