Warner Chilcott Deutschland GmbH
⚠️ High Risk
FEI: 3002808032 • Weiterstadt, Hesse • GERMANY
FEI Number
3002808032
Location
Weiterstadt, Hesse
Country
GERMANYAddress
Dr.-Otto-Rohm-Str. 2/4, , Weiterstadt, Hesse, 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
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/7/2007 | 60LCC85MESALAMINE (ANALGESIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/7/2007 | 60LCC85MESALAMINE (ANALGESIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/7/2007 | 60LCC85MESALAMINE (ANALGESIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/7/2007 | 60LCC18CYCLAZOCINE (ANALGESIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/7/2007 | 60LCC18CYCLAZOCINE (ANALGESIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/13/2007 | 60LCC85MESALAMINE (ANALGESIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/13/2007 | 60LCC85MESALAMINE (ANALGESIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/13/2007 | 60LCC85MESALAMINE (ANALGESIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/13/2007 | 60LCC85MESALAMINE (ANALGESIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/13/2007 | 60LCC85MESALAMINE (ANALGESIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/13/2007 | 60LCC85MESALAMINE (ANALGESIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 1/17/2006 | 61HCC18AMINOSALICYLIC ACID (ANTI-BACTERIAL) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 7/29/2005 | 61HCC18AMINOSALICYLIC ACID (ANTI-BACTERIAL) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/14/2005 | 61HCC18AMINOSALICYLIC ACID (ANTI-BACTERIAL) | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Warner Chilcott Deutschland GmbH's FDA import refusal history?
Warner Chilcott Deutschland GmbH (FEI: 3002808032) has 14 FDA import refusal record(s) in our database, spanning from 7/14/2005 to 8/7/2007.
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. Warner Chilcott Deutschland GmbH's FEI number is 3002808032.
What types of violations has Warner Chilcott Deutschland GmbH received?
Warner Chilcott Deutschland 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 Warner Chilcott Deutschland GmbH come from?
All FDA import refusal data for Warner Chilcott Deutschland 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.