Mcneil Gmbh & Co
⚠️ Moderate Risk
FEI: 3005690785 • Bad Honnef • UNITED KINGDOM
FEI Number
3005690785
Location
Bad Honnef
Country
UNITED KINGDOMAddress
Rhondorfer Strabe 80, , Bad Honnef, , United Kingdom
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
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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 |
|---|---|---|---|
| 7/29/2009 | 62GCA49NAPROXEN (ANTI-INFLAMMATORY) | 472NO ENGLISH | New Orleans District Office (NOL-DO) |
| 7/29/2009 | 66VIP99MISCELLANEOUS PATENT MEDICINES, ETC. | 472NO ENGLISH | New Orleans District Office (NOL-DO) |
| 2/7/2008 | 62KAA08LOPERAMIDE HYDROCHLORIDE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Mcneil Gmbh & Co's FDA import refusal history?
Mcneil Gmbh & Co (FEI: 3005690785) has 3 FDA import refusal record(s) in our database, spanning from 2/7/2008 to 7/29/2009.
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. Mcneil Gmbh & Co's FEI number is 3005690785.
What types of violations has Mcneil Gmbh & Co received?
Mcneil Gmbh & Co 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 Mcneil Gmbh & Co come from?
All FDA import refusal data for Mcneil Gmbh & Co 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.