FDA Inspection
Jurox Pty LtdJurox Pty Ltd – FDA Inspection, Sep 25, 2015
Record Details
This FDA Inspection record concerns Jurox Pty Ltd, with an inspection on September 25, 2015, issued by the Center for Veterinary Medicine, covering veterinary.
- Company
- Jurox Pty Ltd
- Inspection Date
- September 25, 2015
- Product Type
- Veterinary
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ID · e27e8cd6-e3e8-4397-a651-6532326f327a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 945592
- FDA center
- Animal Drugs & Feeds
- Project area
- Pre-Approval Eval. of Animal Drugs and Food Additives
FDA Citations
13- 21 CFR 211.198(b)(1)Complaint Record required information
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
- 21 CFR 211.170(b)Annual visual exams of drug products
- 21 CFR 211.42(c)Defined areas of adequate size for operations
- 21 CFR 211.22(c)Approve or reject procedures or specs
- 21 CFR 211.192Investigations of discrepancies, failures
Showing 10 of 13 citations.
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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 |
| December 21, 2018 | OAI | 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 1075476 - 2018-12-21
- FDA Inspection 755967 - 2011-11-04
- FDA Inspection 700808 - 2010-11-11
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