FDA inspection
Bioretec Ltd: FDA inspection ending Jan 23, 2025
FDA inspection 1259316 · Voluntary Action Indicated (VAI) · Tampere
Key facts
| Inspection ID | 1259316 |
|---|---|
| Firm | Bioretec Ltd |
| FEI number | 3005536892 |
| Address | Yrittajankulma 5 |
| City | Tampere |
| Country | Finland |
| Fiscal year | 2025 |
| Inspection end date | Jan 23, 2025 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Postmarket Assurance: 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