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North Coast Medical Inc

⚠️ Moderate Risk

FEI: 1000124207 • Morgan Hill, CA • UNITED STATES

FEI

FEI Number

1000124207

📍

Location

Morgan Hill, CA

🇺🇸
🏢

Address

135 E Main Ave Ste 110, , Morgan Hill, CA, United States

Moderate Risk

FDA Import Risk Assessment

35.9
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/8/2023
Latest Refusal
12/8/2023
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
57.7×20%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

Refusal History

DateProductViolationsDivision
12/8/2023
89ILHSPLINT, HAND, AND COMPONENTS
118NOT LISTED
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is North Coast Medical Inc's FDA import refusal history?

North Coast Medical Inc (FEI: 1000124207) has 1 FDA import refusal record(s) in our database, spanning from 12/8/2023 to 12/8/2023.

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. North Coast Medical Inc's FEI number is 1000124207.

What types of violations has North Coast Medical Inc received?

North Coast Medical Inc 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 North Coast Medical Inc come from?

All FDA import refusal data for North Coast Medical Inc 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.