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MERCK SERONO LTD

⚠️ Moderate Risk

FEI: 3012679629 • Feltham, Middlesex • UNITED KINGDOM

FEI

FEI Number

3012679629

📍

Location

Feltham, Middlesex

🇬🇧
🏢

Address

Voyager House, Stanwell Road, Feltham, Middlesex, United Kingdom

Moderate Risk

FDA Import Risk Assessment

44.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

3
Total Refusals
1
Unique Violations
2/22/2019
Latest Refusal
4/27/2017
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
16.4×10%
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

753×

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

DateProductViolationsDivision
2/22/2019
64MCA13CETRORELIX ACETATE (GONAD-STIMULATING PRINCIPLE)
75UNAPPROVED
Division of Southeast Imports (DSEI)
2/22/2019
64MCA13CETRORELIX ACETATE (GONAD-STIMULATING PRINCIPLE)
75UNAPPROVED
Division of Southeast Imports (DSEI)
4/27/2017
64MDY07FOLLISTIM (FOLLITROPIN BETA(RDNA)) (GONAD-STIMULATING PRINCIPLE)
75UNAPPROVED
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is MERCK SERONO LTD's FDA import refusal history?

MERCK SERONO LTD (FEI: 3012679629) has 3 FDA import refusal record(s) in our database, spanning from 4/27/2017 to 2/22/2019.

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. MERCK SERONO LTD's FEI number is 3012679629.

What types of violations has MERCK SERONO LTD received?

MERCK SERONO LTD 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 MERCK SERONO LTD come from?

All FDA import refusal data for MERCK SERONO LTD 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.