FDA Inspection
EuroAPI Hungary Ltd.EuroAPI Hungary Ltd. – FDA Inspection, Mar 3, 2017
Record Details
This FDA Inspection record concerns EuroAPI Hungary Ltd., with an inspection on March 3, 2017, issued by the Center for Veterinary Medicine, covering veterinary.
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ID · 31673bd5-6c8e-43af-9deb-82510ccc5db4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1007848
- FDA center
- Animal Drugs & Feeds
- Project area
- Monitoring of Marketed Animal Drugs, Feed, and Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.194(a)(5)Calculations performed are in the records
- 21 CFR 211.194(a)Complete test data included in records
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Other FDA inspections of EuroAPI Hungary Ltd.
5| Date | Classification | Office | Project area |
|---|---|---|---|
| July 8, 2025 | Not classified | Office of Inspections and Investigations | |
| June 21, 2019 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 20, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 30, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 4, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for EuroAPI Hungary Ltd.
- FDA Inspection 1278492 - 2025-07-08
- FDA Inspection 1098971 - 2019-06-21
- FDA Inspection 1087962 - 2018-04-20
- FDA Inspection 883136 - 2014-05-30
- FDA Inspection 645825 - 2010-02-04
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