FDA Inspection 969055 — Aspen SA Sterile Operations (Pty) Ltd.
The FDA completed an inspection of Aspen SA Sterile Operations (Pty) Ltd. on Apr 19, 2016 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 19, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Port Elizabeth (South Africa)
Citations
| ID | CFR | Description |
|---|---|---|
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |