FDA Inspection 1074310 — Aspen SA Sterile Operations (Pty) Ltd.
The FDA completed an inspection of Aspen SA Sterile Operations (Pty) Ltd. on Dec 4, 2018 in Port Elizabeth. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 4, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Port Elizabeth (South Africa)