FDA Inspection 1013188 — Parnell Manufacturing Pty, Ltd.
The FDA completed an inspection of Parnell Manufacturing Pty, Ltd. on Apr 11, 2017 in Alexandria. 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: Veterinary.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 11, 2017
- Fiscal Year
- 2017
- Product Type
- Veterinary
- Project Area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Location
- Alexandria (Australia)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |