FDA Inspection
Zoetis Belgium S.A.Zoetis Belgium S.A. – FDA Inspection, Aug 25, 2016
Record Details
This FDA Inspection record concerns Zoetis Belgium S.A., with an inspection on August 25, 2016, issued by the Center for Veterinary Medicine, covering veterinary.
- Company
- Zoetis Belgium S.A.
- Inspection Date
- August 25, 2016
- Product Type
- Veterinary
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ID · f0d70fb7-778b-4553-94eb-5efdd7ca8c36
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 986012
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
FDA Citations
3- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.100(b)SOPs not followed / documented
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Other FDA inspections of Zoetis Belgium S.A.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| May 21, 2024 | NAI | Center for Veterinary Medicine | Pre-Approval Eval. of Animal Drugs and Food Additives |
| November 22, 2022 | VAI | Center for Veterinary Medicine | Pre-Approval Eval. of Animal Drugs and Food Additives |
| October 21, 2022 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
| January 27, 2015 | VAI | Center for Veterinary Medicine | Pre-Approval Eval. of Animal Drugs and Food Additives |
| July 5, 2013 | VAI | Center for Veterinary Medicine | Monitoring of Marketed Animal Drugs, Feed, and Devices |
Other documents for Zoetis Belgium S.A.
- FDA Inspection 1247453 - 2024-05-21
- FDA Inspection 1191120 - 2022-11-22
- FDA Inspection 1214528 - 2022-10-21
- FDA Inspection 919187 - 2015-01-27
- FDA Inspection 841521 - 2013-07-05
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