Aspen SA Sterile Operations (Pty) Ltd.
Aspen SA Sterile Operations (Pty) Ltd. has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 1 compliance action on record.
- Latest inspection
- Jul 14, 2026 · OAI
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 6 | Nov 8, 2026 | Newest record Oct 28, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jul 14, 2026 | Port Elizabeth, South Africa | Drugs | Official Action Indicated (OAI) | 3007490529 |
| Sep 17, 2024 | Port Elizabeth, South Africa | Drugs | Official Action Indicated (OAI) | 3007490529 |
| Dec 4, 2018 | Port Elizabeth, South Africa | Drugs | Voluntary Action Indicated (VAI) | 3007490529 |
| Apr 19, 2016 | Port Elizabeth, South Africa | Drugs | Voluntary Action Indicated (VAI) | 3007490529 |
| May 23, 2014 | Port Elizabeth, South Africa | Drugs | No Action Indicated (NAI) | 3007490529 |
| May 17, 2012 | Port Elizabeth, South Africa | Drugs | No Action Indicated (NAI) | 3007490529 |
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3007490529 | Port Elizabeth, South Africa | 6 | Jul 14, 2026 |