FDA inspection
Biocon Sdn Bhd: FDA inspection ending Sep 24, 2021
FDA inspection 1156161 · Official Action Indicated (OAI) · Iskandar Puteri
Key facts
| Inspection ID | 1156161 |
|---|---|
| Firm | Biocon Sdn Bhd |
| FEI number | 3011248248 |
| Address | No. 1., Jalan Biooteknologi 1, Kawasan Perindustrian Silc |
| City | Iskandar Puteri |
| Fiscal year | 2021 |
| Inspection end date | Sep 24, 2021 |
| Classification | Official Action Indicated (OAI) |
| Project area | New Drug Evaluation |
| Product type | Drugs |
At a glance
- None 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