FDA Inspection 785656 — ENERGIST LIMITED
The FDA completed an inspection of ENERGIST LIMITED on May 24, 2012 in Swansea. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 24, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Swansea (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 454 | 21 CFR 820.40(a) | Document review, approval by designated individual |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |