FDA inspection
Cochlear Bone Anchored Solutions AB: FDA inspection ending May 17, 2007
FDA inspection 473315 · Official Action Indicated (OAI) · Molnlycke
Key facts
| Inspection ID | 473315 |
|---|---|
| Firm | Cochlear Bone Anchored Solutions AB |
| FEI number | 3003222064 |
| Address | Konstruktionsvagen 14 |
| City | Molnlycke |
| Fiscal year | 2007 |
| Inspection end date | May 17, 2007 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Med Devices |
| Product type | Devices |
| Warning letter | UCM1048394 |
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