FDA Inspection
Parnell Manufacturing Pty, Ltd.Parnell Manufacturing Pty, Ltd. – FDA Inspection, Jun 9, 2026
Record Details
This FDA Inspection record concerns Parnell Manufacturing Pty, Ltd., with an inspection on June 9, 2026, issued by the Office of Inspections and Investigations, covering animal drugs & feeds.
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ID · d5b7283b-f547-4f4c-ab9d-600864530a10
Inspection Facts
- Inspection number
- 1321304
- FDA center
- Animal Drugs & Feeds
- Project area
- Pre-Approval Eval. of Animal Drugs and Food Additives
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.42(c)(10)(v)Cleaning System
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Other FDA inspections of Parnell Manufacturing Pty, Ltd.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 17, 2024 | OAI | Office of Inspections and Investigations | Pre-Approval Evaluation of Animal Drugs and Food Additives |
| July 19, 2019 | NAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| April 11, 2017 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| June 23, 2015 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| September 20, 2012 | VAI | Center for Veterinary Medicine | Pre-Approval Eval. of Animal Drugs and Food Additives |
Other documents for Parnell Manufacturing Pty, Ltd.
- FDA Inspection 1249317 - 2024-09-17
- FDA Inspection 1100264 - 2019-07-19
- FDA Inspection 1013188 - 2017-04-11
- FDA Inspection 935983 - 2015-06-23
- FDA Inspection 800584 - 2012-09-20
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