FDA Inspection 1074310 — Aspen SA Sterile Operations (Pty) Ltd.
The FDA completed an inspection of Aspen SA Sterile Operations (Pty) Ltd. on December 4, 2018 in Port Elizabeth. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 4, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Port Elizabeth (South Africa)