FDA inspection
Biora AB: FDA inspection ending May 25, 2000
FDA inspection 25582 · Voluntary Action Indicated (VAI) · Malmo
Key facts
| Inspection ID | 25582 |
|---|---|
| Firm | Biora AB |
| FEI number | 3002806508 |
| Address | Amersham Health R&D Ab, Medeon Science Park |
| City | Malmo |
| Fiscal year | 2000 |
| Inspection end date | May 25, 2000 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Product Evaluation: Med Devices |
| Product type | Devices |
| Warning letter | UCM068628 |
At a glance
- None Citations
- 1–9 Posted citations
- Yes 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