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Genzyme Biosurgery

⚠️ Moderate Risk

FEI: 3001451515 • Lexington, MA • UNITED STATES

FEI

FEI Number

3001451515

📍

Location

Lexington, MA

🇺🇸
🏢

Address

4 Maguire Rd, , Lexington, MA, United States

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
12/19/2003
Latest Refusal
12/19/2003
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
12/19/2003
76MGGFLUID, HYLAN (FOR TMJ USE)
84RX DEVICE
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Genzyme Biosurgery's FDA import refusal history?

Genzyme Biosurgery (FEI: 3001451515) has 1 FDA import refusal record(s) in our database, spanning from 12/19/2003 to 12/19/2003.

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 Biosurgery's FEI number is 3001451515.

What types of violations has Genzyme Biosurgery received?

Genzyme Biosurgery 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 Biosurgery come from?

All FDA import refusal data for Genzyme Biosurgery 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.