1258084
Helena Laboratories UK Ltd — FEI 3009736003
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- January 9, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Gateshead Newcastle (United Kingdom)
Citations
| ID | CFR | Description |
|---|
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 22795 | 21 CFR 801.20(a) | Label to bear a unique device identifier |
| 633 | 21 CFR 803.17(a)(3) | Lack of System for Timely Submission of Reports |