FDA Inspection 1029998 — Phebra Pty Ltd
The FDA completed an inspection of Phebra Pty Ltd on October 27, 2017 in Lane Cove West. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 27, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Lane Cove West (Australia)
Citations
| ID | CFR | Description |
|---|---|---|
| 1219 | 21 CFR 211.67(b)(2) | Cleaning SOPs/schedules |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 3548 | 21 CFR 211.46(c) | Air filtration system lacking in production area |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |