FDA Inspection 873771 — Contract Pharmaceutical Services of Australia Pty Ltd
The FDA completed an inspection of Contract Pharmaceutical Services of Australia Pty Ltd on February 13, 2014 in Macquarie Park. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 13, 2014
- Fiscal Year
- 2014
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Macquarie Park (Australia)
Citations
| ID | CFR | Description |
|---|---|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |