FDA inspection
Helena Laboratories UK Ltd: FDA inspection ending Jan 9, 2025
FDA inspection 1258084 · Voluntary Action Indicated (VAI) · Gateshead Newcastle
Key facts
| Inspection ID | 1258084 |
|---|---|
| Firm | Helena Laboratories UK Ltd |
| FEI number | 3009736003 |
| Address | Queensway South, Team Valley Trading Estate |
| City | Gateshead Newcastle |
| Country | United Kingdom |
| Fiscal year | 2025 |
| Inspection end date | Jan 9, 2025 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data