FDA inspection
Polaroisin International Co., Ltd.: FDA inspection ending Sep 15, 2017
FDA inspection 1028352 · Official Action Indicated (OAI) · New Taipei City
Key facts
| Inspection ID | 1028352 |
|---|---|
| Firm | Polaroisin International Co., Ltd. |
| FEI number | 3008004582 |
| Address | Xinzhuang District, NO 173, 10 F; Siyuan Rd. |
| City | New Taipei City |
| Country | Taiwan |
| Fiscal year | 2017 |
| Inspection end date | Sep 15, 2017 |
| Classification | Official Action Indicated (OAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
| Warning letter | 541792 |
At a glance
- 1–9 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