Company
HungaryEuroAPI Hungary Ltd., Budapest, Hungary – FDA Inspections
Inspection records and compliance data for EuroAPI Hungary Ltd. in Budapest. 6 FDA inspections on record, 1 Form 483, last inspected July 08, 2025.
Company Profile
This profile covers EuroAPI Hungary Ltd. based in Budapest, Hungary.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 2
- NAI
- 3
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected February 4, 2010. Last inspected July 8, 2025.
Most cited issue areas
- Calculations performed are in the records1 inspection
- Complete test data included in records1 inspection
- Scientifically sound laboratory controls1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 8, 2025 | Not classified | Human Drugs | 1278492 |
| June 21, 2019 | NAI | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 1098971 |
| April 20, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1087962 |
| March 3, 2017 | VAI | Animal Drugs & Feeds · Monitoring of Marketed Animal Drugs, Feed, and Devices | 1007848 |
| May 30, 2014 | NAI | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 883136 |
| February 4, 2010 | NAI | Human Drugs · Drug Quality Assurance | 645825 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Other regulators (1)
- Health Canada · 2 inspections · last September 27, 2024
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
EuroAPI Hungary Ltd.
FEI Number
3002806675
Address
To Utca 1-5, Budapest, Hungary
Country
Hungary
ID: d205fd54-e9b2-41c9-a400-20091c22d4c0