Gedeon Richter Nyrt.
⚠️ High Risk
FEI: 3002806761 • Budapest, Budapest • HUNGARY
FEI Number
3002806761
Location
Budapest, Budapest
Country
HUNGARYAddress
Gyomroi Ut 19-21, , 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).
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.
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/5/2025 | 64GCA27DESOGESTREL/ETHINYL ESTRADIOL (ESTROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/1/2023 | 64GDY07ESTRADIOL (ESTROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/30/2020 | 66FCJ99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/4/2020 | 65JCA04CHLORMADIONONE ACETATE (PROGESTIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/17/2020 | 62ODA40LISINOPRIL (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/8/2020 | 65JDA99PROGESTIN N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/7/2019 | 64GDA07ESTRADIOL (ESTROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/29/2019 | 62FDA99ANTI-INFECTIVE, TOPICAL N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/4/2018 | 66FDB99SUPPRESSANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/25/2017 | 64LCJ60TRIAMCINOLONE (GLUCOCORTICOID) | Division of Northeast Imports (DNEI) | |
| 5/25/2017 | 61XCA09CINNARIZINE (ANTI-HISTAMINIC) | Division of Northeast Imports (DNEI) | |
| 5/24/2017 | 62LCA99ANTI-PROTOZOAL, ANTI-LEISHMANIAL, ANTI-MALARIAL, N.E.C. | Division of Northeast Imports (DNEI) | |
| 2/8/2017 | 64GBA19ETHINYL ESTRADIOL (ESTROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/22/2016 | 62ODA14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/7/2016 | 64GBA07ESTRADIOL (ESTROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/10/2016 | 66VCE99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 7/1/2016 | 62CDA65LISINOPRIL (ANTI-HYPERTENSIVE) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/16/2016 | 62CCA65LISINOPRIL (ANTI-HYPERTENSIVE) | Florida District Office (FLA-DO) | |
| 3/10/2016 | 64GDC19ETHINYL ESTRADIOL (ESTROGEN) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/2/2016 | 62OCC28ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/15/2015 | 64GIY07ESTRADIOL (ESTROGEN) | Division of Northeast Imports (DNEI) | |
| 10/27/2011 | 64GDB27DESOGESTREL/ETHINYL ESTRADIOL (ESTROGEN) | New Orleans District Office (NOL-DO) | |
| 10/27/2011 | 61BIS05FLUTAMIDE (ANTI-ANDROGEN) | New Orleans District Office (NOL-DO) | |
| 3/7/2011 | 54FBT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Los Angeles District Office (LOS-DO) | |
| 1/4/2011 | 62ZCP04TRIPTORELIN PAMOATE (ANTI-NEOPLASTIC - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/3/2008 | 61PCP31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/30/2007 | 60LAB05ASPIRIN (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/31/2005 | 64GIF29LEVONORGESTREL (ESTROGEN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/26/2005 | 62CDA99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 5/11/2005 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 473LABELING | Florida District Office (FLA-DO) |
| 3/21/2005 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Gedeon Richter Nyrt.'s FDA import refusal history?
Gedeon Richter Nyrt. (FEI: 3002806761) has 31 FDA import refusal record(s) in our database, spanning from 3/21/2005 to 8/5/2025.
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. Gedeon Richter Nyrt.'s FEI number is 3002806761.
What types of violations has Gedeon Richter Nyrt. received?
Gedeon Richter Nyrt. has been cited for 6 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 Gedeon Richter Nyrt. come from?
All FDA import refusal data for Gedeon Richter Nyrt. 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.