Delpharm Huningue S.A.S.
⚠️ High Risk
FEI: 3003157245 • Huningue, Haut Rhin • FRANCE
FEI Number
3003157245
Location
Huningue, Haut Rhin
Country
FRANCEAddress
26 rue de la Chapelle, BP 349, Huningue, Haut Rhin, France
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 |
|---|---|---|---|
| 6/20/2023 | 60LCL14CARBAMAZEPINE (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/15/2021 | 60LCY14CARBAMAZEPINE (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/15/2014 | 55YY99PHARMACEUTIC NECESSITIES AND CONTAINERS, N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 1/4/2007 | 65UDM02TRIBENOSIDE (SCLEROSING AGENT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 1/4/2007 | 65UDM02TRIBENOSIDE (SCLEROSING AGENT) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 1/24/2003 | 60LCM99ANALGESIC, N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Delpharm Huningue S.A.S.'s FDA import refusal history?
Delpharm Huningue S.A.S. (FEI: 3003157245) has 6 FDA import refusal record(s) in our database, spanning from 1/24/2003 to 6/20/2023.
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. Delpharm Huningue S.A.S.'s FEI number is 3003157245.
What types of violations has Delpharm Huningue S.A.S. received?
Delpharm Huningue S.A.S. 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 Delpharm Huningue S.A.S. come from?
All FDA import refusal data for Delpharm Huningue S.A.S. 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.