FDA Inspection
Zoetis LLCZoetis LLC – FDA Inspection, Feb 13, 2024
Record Details
This FDA Inspection record concerns Zoetis LLC, with an inspection on February 13, 2024, issued by the Center for Veterinary Medicine, covering veterinary.
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ID · 5d0ed9ff-00d1-4199-ac99-8389aa60760f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1230798
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
7- 21 CFR 211.42(c)(10)(i)Floors, walls, ceiling surfaces
- 21 CFR 211.63Equipment Design, Size and Location
- 21 CFR 211.194(a)(4)Complete Test Data
- 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 211.100(a)Absence of Written Procedures
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Other FDA inspections of Zoetis LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 3, 2021 | VAI | Center for Veterinary Medicine | Pre-Approval Eval. of Animal Drugs and Food Additives |
| April 11, 2019 | NAI | Center for Veterinary Medicine | Pre-Approval Eval. of Animal Drugs and Food Additives |
| August 19, 2016 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 29, 2015 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 17, 2014 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Zoetis LLC
- FDA Inspection 1141156 - 2021-05-03
- FDA Inspection 1088266 - 2019-04-11
- FDA Inspection 987221 - 2016-08-19
- FDA Inspection 931788 - 2015-06-29
- FDA Inspection 874793 - 2014-04-17
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