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Datascope Corp.

⚠️ Moderate Risk

FEI: 3001418283 • Mahwah, NJ • UNITED STATES

FEI

FEI Number

3001418283

📍

Location

Mahwah, NJ

🇺🇸
🏢

Address

1300 Macarthur Blvd, , Mahwah, NJ, United States

Moderate Risk

FDA Import Risk Assessment

35.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
1/9/2013
Latest Refusal
1/9/2013
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

4792×

DV QUALITY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.

Refusal History

DateProductViolationsDivision
1/9/2013
74DSPSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
479DV QUALITY
New York District Office (NYK-DO)
1/9/2013
74DSPSYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
479DV QUALITY
New York District Office (NYK-DO)

Frequently Asked Questions

What is Datascope Corp.'s FDA import refusal history?

Datascope Corp. (FEI: 3001418283) has 2 FDA import refusal record(s) in our database, spanning from 1/9/2013 to 1/9/2013.

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. Datascope Corp.'s FEI number is 3001418283.

What types of violations has Datascope Corp. received?

Datascope 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 Datascope Corp. come from?

All FDA import refusal data for Datascope 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.