FDA Inspection 1249317 — Parnell Manufacturing Pty, Ltd.
The FDA completed an inspection of Parnell Manufacturing Pty, Ltd. on Sep 17, 2024 in Alexandria. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Veterinary.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Sep 17, 2024
- Fiscal Year
- 2024
- Product Type
- Veterinary
- Project Area
- Pre-Approval Eval. of Animal Drugs and Food Additives
- Location
- Alexandria (Australia)
Citations
| ID | CFR | Description |
|---|---|---|
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |