ImportRefusal LogoImportRefusal

Shelby Scientific

⚠️ Moderate Risk

FEI: 3002707171 • Shelby Township, MI • UNITED STATES

FEI

FEI Number

3002707171

📍

Location

Shelby Township, MI

🇺🇸
🏢

Address

55670 Parkview Dr, , Shelby Township, MI, 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
11/5/2002
Latest Refusal
11/5/2002
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

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

Refusal History

DateProductViolationsDivision
11/5/2002
80LSXCONTROLLER, CLOSED-LOOP, BLOOD-PRESSURE
16DIRECTIONS
New York District Office (NYK-DO)

Frequently Asked Questions

What is Shelby Scientific's FDA import refusal history?

Shelby Scientific (FEI: 3002707171) has 1 FDA import refusal record(s) in our database, spanning from 11/5/2002 to 11/5/2002.

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. Shelby Scientific's FEI number is 3002707171.

What types of violations has Shelby Scientific received?

Shelby Scientific 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 Shelby Scientific come from?

All FDA import refusal data for Shelby Scientific 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.