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EMD Serono, Inc.

⚠️ Moderate Risk

FEI: 1220970 • Boston, MA • UNITED STATES

FEI

FEI Number

1220970

📍

Location

Boston, MA

🇺🇸
🏢

Address

200 Pier 4 Blvd Ste 300, , Boston, MA, United States

Moderate Risk

FDA Import Risk Assessment

42.1
LowModerateHighCritical

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

Statistics

7
Total Refusals
2
Unique Violations
6/28/2018
Latest Refusal
2/18/2010
Earliest Refusal

Score Breakdown

Violation Severity
78.0×40%
Refusal Volume
33.5×30%
Recency
0.0×20%
Frequency
8.4×10%
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

757×

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).

1183×

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

DateProductViolationsDivision
6/28/2018
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
Division of Northern Border Imports (DNBI)
6/28/2018
64MDY13CETRORELIX ACETATE (GONAD-STIMULATING PRINCIPLE)
118NOT LISTED
75UNAPPROVED
Division of Northern Border Imports (DNBI)
6/28/2018
64MDY07FOLLISTIM (FOLLITROPIN BETA(RDNA)) (GONAD-STIMULATING PRINCIPLE)
118NOT LISTED
75UNAPPROVED
Division of Northern Border Imports (DNBI)
2/18/2010
64MCK14CHORIOGONADOTROPIN ALFA (GONAD-STIMULATING PRINCIPLE)
75UNAPPROVED
New Orleans District Office (NOL-DO)
2/18/2010
64MCK13CETRORELIX ACETATE (GONAD-STIMULATING PRINCIPLE)
75UNAPPROVED
New Orleans District Office (NOL-DO)
2/18/2010
64MCK07FOLLISTIM (FOLLITROPIN BETA(RDNA)) (GONAD-STIMULATING PRINCIPLE)
75UNAPPROVED
New Orleans District Office (NOL-DO)
2/18/2010
64MCK07FOLLISTIM (FOLLITROPIN BETA(RDNA)) (GONAD-STIMULATING PRINCIPLE)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is EMD Serono, Inc.'s FDA import refusal history?

EMD Serono, Inc. (FEI: 1220970) has 7 FDA import refusal record(s) in our database, spanning from 2/18/2010 to 6/28/2018.

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. EMD Serono, Inc.'s FEI number is 1220970.

What types of violations has EMD Serono, Inc. received?

EMD Serono, Inc. 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 EMD Serono, Inc. come from?

All FDA import refusal data for EMD Serono, Inc. 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.