FDA Inspection 1258084 — Helena Laboratories UK Ltd
The FDA completed an inspection of Helena Laboratories UK Ltd on Jan 9, 2025 in Gateshead Newcastle. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 9, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: 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 |