FDA Inspection 1321304 — Parnell Manufacturing Pty, Ltd.
The FDA completed an inspection of Parnell Manufacturing Pty, Ltd. on Jun 9, 2026 in Alexandria. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 5 citations were issued during this inspection. Product area: Veterinary.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jun 9, 2026
- Fiscal Year
- 2026
- Product Type
- Veterinary
- Project Area
- Pre-Approval Eval. of Animal Drugs and Food Additives
- Location
- Alexandria (Australia)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |