Denk Pharma
⚠️ Moderate Risk
FEI: 3005224455 • Munich • GERMANY
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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 |
|---|---|---|---|
| 3/9/2016 | 62OCY14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 12/17/2014 | 64LCB40HYDROCORTISONE SODIUM PHOSPHATE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/22/2010 | 66SCA27NIFEDIPINE (VASODILATOR) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 9/3/2008 | 62LBN50METRONIDAZOLE HYDROCHLORIDE (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Denk Pharma's FDA import refusal history?
Denk Pharma (FEI: 3005224455) has 4 FDA import refusal record(s) in our database, spanning from 9/3/2008 to 3/9/2016.
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. Denk Pharma's FEI number is 3005224455.
What types of violations has Denk Pharma received?
Denk Pharma 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 Denk Pharma come from?
All FDA import refusal data for Denk Pharma 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.