Medice Arzneimittel Puetter Gmbh
⚠️ High Risk
FEI: 3008781218 • Iserlohn, Nordrhein-westfalen • GERMANY
FEI Number
3008781218
Location
Iserlohn, Nordrhein-westfalen
Country
GERMANYAddress
Kuhloweg 37, , Iserlohn, Nordrhein-westfalen, Germany
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
Frequently Asked Questions
What is Medice Arzneimittel Puetter Gmbh's FDA import refusal history?
Medice Arzneimittel Puetter Gmbh (FEI: 3008781218) has 2 FDA import refusal record(s) in our database, spanning from 10/14/2025 to 1/9/2026.
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. Medice Arzneimittel Puetter Gmbh's FEI number is 3008781218.
What types of violations has Medice Arzneimittel Puetter Gmbh received?
Medice Arzneimittel Puetter Gmbh 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 Medice Arzneimittel Puetter Gmbh come from?
All FDA import refusal data for Medice Arzneimittel Puetter Gmbh 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.