FDA inspection
Molteno Ophthalmic Limited: FDA inspection ending Dec 2, 2009
FDA inspection 634822 · Official Action Indicated (OAI) · Dunedin
Key facts
| Inspection ID | 634822 |
|---|---|
| Firm | Molteno Ophthalmic Limited |
| FEI number | 3001227772 |
| Address | 152 Frederick Street |
| City | Dunedin |
| Country | New Zealand |
| Fiscal year | 2010 |
| Inspection end date | Dec 2, 2009 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
| Warning letter | 105145 |
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