FDA Warning Letter — Aspen SA Sterile Operations (Pty) Ltd.
The FDA took a Warning Letter action against Aspen SA Sterile Operations (Pty) Ltd. on February 24, 2025 (Port Elizabeth, South Africa). The action was issued by CDER and concerns drugs products. This facility has 5 or more recent FDA inspections on record.
Action Details
- Facility
- Aspen SA Sterile Operations (Pty) Ltd.
- Date
- February 24, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Center
- CDER
- Location
- Port Elizabeth (South Africa)