FDA Inspection 1034492 — Aspen SA OSD Operations Pty Ltd.
The FDA completed an inspection of Aspen SA OSD Operations Pty Ltd. on Dec 8, 2017 in Korsten. 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 8, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Korsten (South Africa)
Citations
| ID | CFR | Description |
|---|---|---|
| 1454 | 21 CFR 211.115(a) | Reprocessing procedures not written or followed |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |