FDA inspection
Novugen Pharma Sdn Bhd: FDA inspection ending Sep 7, 2022
FDA inspection 1178936 · Voluntary Action Indicated (VAI) · Bandar Baru Eenstek
Key facts
| Inspection ID | 1178936 |
|---|---|
| Firm | Novugen Pharma Sdn Bhd |
| FEI number | 3017604745 |
| Address | No 27, Jalan Lengkuk Teknologi 2, Taman Teknologi Enstek Fasa 1 |
| City | Bandar Baru Eenstek |
| Fiscal year | 2022 |
| Inspection end date | Sep 7, 2022 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Generic Drug Evaluation |
| Product type | Drugs |
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