FDA inspection
Aspen SA Sterile Operations (Pty) Ltd.: FDA inspection ending Sep 17, 2024
FDA inspection 1249416 · Official Action Indicated (OAI) · Port Elizabeth
Key facts
| Inspection ID | 1249416 |
|---|---|
| Firm | Aspen SA Sterile Operations (Pty) Ltd. |
| FEI number | 3007490529 |
| Address | 8b Gibaud Road |
| City | Port Elizabeth |
| Country | South Africa |
| Fiscal year | 2024 |
| Inspection end date | Sep 17, 2024 |
| Classification | Official Action Indicated (OAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
| Warning letter | 701671 |
At a glance
- 10–99 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