ImportRefusal LogoImportRefusal

Genzyme

⚠️ Moderate Risk

FEI: 3006848390 • Langley, BRITISH COLUMBIA • CANADA

FEI

FEI Number

3006848390

📍

Location

Langley, BRITISH COLUMBIA

🇨🇦

Country

CANADA
🏢

Address

16-19977 71st Ave, , Langley, BRITISH COLUMBIA, Canada

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
8/19/2009
Latest Refusal
8/19/2009
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

841×

RX DEVICE

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.

Refusal History

DateProductViolationsDivision
8/19/2009
87JDNIMPLANT, FIXATION DEVICE, SPINAL
84RX DEVICE
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Genzyme's FDA import refusal history?

Genzyme (FEI: 3006848390) has 1 FDA import refusal record(s) in our database, spanning from 8/19/2009 to 8/19/2009.

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. Genzyme's FEI number is 3006848390.

What types of violations has Genzyme received?

Genzyme 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 Genzyme come from?

All FDA import refusal data for Genzyme 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.