Egis Pharmaceuticals PLC
⚠️ High Risk
FEI: 3002806880 • Budapest, Budapest • HUNGARY
FEI Number
3002806880
Location
Budapest, Budapest
Country
HUNGARYAddress
Kereszturi Ut 30-38, , Budapest, Budapest, Hungary
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/7/2025 | 66TDE01ALLOPURINOL (XANTHINE OXIDASE INHIBITOR) | Division of West Coast Imports (DWCI) | |
| 9/6/2022 | 61XCA14CYPROHEPTADINE HCL (ANTI-HISTAMINIC) | Division of Southeast Imports (DSEI) | |
| 4/24/2020 | 62YDA07MELOXICAM (ANTI-INFLAMMATORY, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/18/2018 | 61XCA14CYPROHEPTADINE HCL (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/24/2017 | 61XCA99ANTI-HISTAMINIC N.E.C. | Division of Northeast Imports (DNEI) | |
| 7/29/2016 | 66MDA03ALPRAZOLAM (TRANQUILIZER) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/9/2016 | 62OCY22CARVEDILOL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/21/2011 | 61NCP78SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT) | Division of Southeast Imports (DSEI) | |
| 10/12/2011 | 66SCC28NITROGLYCERIN (TAB) (VASODILATOR) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/22/2010 | 54CFA01L-ALANINE (PROTEIN) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/2/2009 | 61UDA05TAMOXIFEN CITRATE (ANTI-ESTROGEN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/3/2008 | 61NCN65CITALOPRAM HYDROBROMIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/5/2006 | 61FAK55CIPROFLOXACIN HYDROCHLORIDE (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/21/2005 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/22/2004 | 66VBC99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/22/2004 | 56BDC03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/23/2003 | 66MCY78CLOBAZAM (TRANQUILIZER) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Egis Pharmaceuticals PLC's FDA import refusal history?
Egis Pharmaceuticals PLC (FEI: 3002806880) has 17 FDA import refusal record(s) in our database, spanning from 12/23/2003 to 5/7/2025.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Egis Pharmaceuticals PLC's FEI number is 3002806880.
What types of violations has Egis Pharmaceuticals PLC received?
Egis Pharmaceuticals PLC has been cited for 5 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Egis Pharmaceuticals PLC come from?
All FDA import refusal data for Egis Pharmaceuticals PLC is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.