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Zoll Medical Corp

⚠️ Moderate Risk

FEI: 3004825185 • Burlington, MA • UNITED STATES

FEI

FEI Number

3004825185

📍

Location

Burlington, MA

🇺🇸
🏢

Address

32 2nd Ave, , Burlington, MA, United States

Moderate Risk

FDA Import Risk Assessment

36.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/20/2023
Latest Refusal
12/20/2023
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
58.3×20%
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

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
12/20/2023
74MKJAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
3280FRNMFGREG
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is Zoll Medical Corp's FDA import refusal history?

Zoll Medical Corp (FEI: 3004825185) has 1 FDA import refusal record(s) in our database, spanning from 12/20/2023 to 12/20/2023.

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. Zoll Medical Corp's FEI number is 3004825185.

What types of violations has Zoll Medical Corp received?

Zoll Medical Corp 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 Zoll Medical Corp come from?

All FDA import refusal data for Zoll Medical Corp 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.