FDA Inspection
Jurox Pty LtdJurox Pty Ltd – FDA Inspection, Dec 21, 2018
Record Details
This FDA Inspection record concerns Jurox Pty Ltd, with an inspection on December 21, 2018, issued by the Center for Veterinary Medicine, covering veterinary.
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ID · 582b3c74-a6be-4084-a81a-7bc6ab303297
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1075476
- FDA center
- Animal Drugs & Feeds
- Project area
- Pre-Approval Eval. of Animal Drugs and Food Additives
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 11Electronic records
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.42(b)Product flow through building is inadequate
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.166(a)(3)Valid stability test methods
- 21 CFR 211.166(a)Written program not followed
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Other FDA inspections of Jurox Pty Ltd
4| Date | Classification | Office | Project area |
|---|---|---|---|
| June 28, 2022 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| September 25, 2015 | VAI | Center for Veterinary Medicine | Pre-Approval Eval. of Animal Drugs and Food Additives |
| November 4, 2011 | VAI | Center for Veterinary Medicine | Pre-Approval Eval. of Animal Drugs and Food Additives |
| November 11, 2010 | OAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for Jurox Pty Ltd
- FDA Inspection 1172980 - 2022-06-28
- FDA Inspection 945592 - 2015-09-25
- FDA Inspection 755967 - 2011-11-04
- FDA Inspection 700808 - 2010-11-11
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