FDA Inspection
Zoetis LLCZoetis LLC – FDA Inspection, May 3, 2021
Record Details
This FDA Inspection record concerns Zoetis LLC, with an inspection on May 3, 2021, issued by the Center for Veterinary Medicine, covering veterinary.
- Company
- Zoetis LLC
- Inspection Date
- May 3, 2021
- Product Type
- Veterinary
View Company Profile
ID · fb6a78a0-2027-46fc-b8d6-67c326d25656
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1141156
- FDA center
- Animal Drugs & Feeds
- Project area
- Pre-Approval Eval. of Animal Drugs and Food Additives
FDA Citations
7- 21 CFR 211.42(c)(10)(v)Cleaning System
- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.56(a)Sanitation--buildings not clean, free of infestation
- 21 CFR 211.110(a)Control procedures to monitor and validate performance
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
- 21 CFR 211.22(d)Procedures not in writing, fully followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Zoetis LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| February 13, 2024 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| 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 1230798 - 2024-02-13
- 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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