Eisai Manufacturing Limited
⚠️ Moderate Risk
FEI: 3008356774 • Hatfield, Hertfordshire • UNITED KINGDOM
FEI Number
3008356774
Location
Hatfield, Hertfordshire
Country
UNITED KINGDOMAddress
European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, 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
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
Frequently Asked Questions
What is Eisai Manufacturing Limited's FDA import refusal history?
Eisai Manufacturing Limited (FEI: 3008356774) has 3 FDA import refusal record(s) in our database, spanning from 3/31/2014 to 5/15/2018.
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. Eisai Manufacturing Limited's FEI number is 3008356774.
What types of violations has Eisai Manufacturing Limited received?
Eisai Manufacturing Limited 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 Eisai Manufacturing Limited come from?
All FDA import refusal data for Eisai Manufacturing Limited 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.