FDA inspection
Aspen Biopharma Labs Pvt., Ltd.: FDA inspection ending Sep 21, 2024
FDA inspection 1251977 · Official Action Indicated (OAI) · Medchal Malkajgiri
Key facts
| Inspection ID | 1251977 |
|---|---|
| Firm | Aspen Biopharma Labs Pvt., Ltd. |
| FEI number | 3012796281 |
| Address | Plot No 10, Biotech Park Phase-II, Lalgadi Malakpet Village,Turkapally, Shameerpet Mandal |
| City | Medchal Malkajgiri |
| Country | India |
| Fiscal year | 2024 |
| Inspection end date | Sep 21, 2024 |
| Classification | Official Action Indicated (OAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
| Warning letter | 698665 |
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