FDA inspection
Osteotec Limited: FDA inspection ending Sep 4, 2018
FDA inspection 1064322 · Official Action Indicated (OAI) · Christchurch
Key facts
| Inspection ID | 1064322 |
|---|---|
| Firm | Osteotec Limited |
| FEI number | 3008395366 |
| Address | Unit 9, Silver Business Park; Airfield Way |
| City | Christchurch |
| Country | United Kingdom |
| Fiscal year | 2018 |
| Inspection end date | Sep 4, 2018 |
| Classification | Official Action Indicated (OAI) |
| 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