FDA inspection
Opto-Pharm Pte Ltd.: FDA inspection ending Mar 22, 2016
FDA inspection 970156 · Official Action Indicated (OAI) · Singapore
Key facts
| Inspection ID | 970156 |
|---|---|
| Firm | Opto-Pharm Pte Ltd. |
| FEI number | 3005320466 |
| Address | 13 Tuas Avenue 12 |
| City | Singapore |
| Country | Singapore |
| Fiscal year | 2016 |
| Inspection end date | Mar 22, 2016 |
| Classification | Official Action Indicated (OAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
| Warning letter | 517254 |
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