Essex Pharma Gmbh
⚠️ Moderate Risk
FEI: 1000303714 • Munich, Bavaria • GERMANY
FEI Number
1000303714
Location
Munich, Bavaria
Country
GERMANYAddress
Thomas-Dehler-Str. 27, , Munich, Bavaria, 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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/22/2011 | 56LKY70TYLOSIN (NON-CERTIFIABLE) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
| 9/2/2009 | 62CDA65LISINOPRIL (ANTI-HYPERTENSIVE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/11/2008 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/25/2005 | 61ECB08LORATADINE (ANTI-ASTHMATIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Essex Pharma Gmbh's FDA import refusal history?
Essex Pharma Gmbh (FEI: 1000303714) has 4 FDA import refusal record(s) in our database, spanning from 10/25/2005 to 6/22/2011.
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. Essex Pharma Gmbh's FEI number is 1000303714.
What types of violations has Essex Pharma Gmbh received?
Essex Pharma Gmbh has been cited for 2 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 Essex Pharma Gmbh come from?
All FDA import refusal data for Essex Pharma 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.