GEDEON RICHTER POLSKA SP ZOO
⚠️ High Risk
FEI: 3017586533 • Grodzisk • POLAND
FEI Number
3017586533
Location
Grodzisk
Country
POLANDAddress
Ul Ksj Poniatowskiego 5, , Grodzisk, , Poland
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/7/2025 | 64BDB25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is GEDEON RICHTER POLSKA SP ZOO's FDA import refusal history?
GEDEON RICHTER POLSKA SP ZOO (FEI: 3017586533) has 1 FDA import refusal record(s) in our database, spanning from 3/7/2025 to 3/7/2025.
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. GEDEON RICHTER POLSKA SP ZOO's FEI number is 3017586533.
What types of violations has GEDEON RICHTER POLSKA SP ZOO received?
GEDEON RICHTER POLSKA SP ZOO has been cited for 1 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 POLSKA SP ZOO come from?
All FDA import refusal data for GEDEON RICHTER POLSKA SP ZOO 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.