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Altus Partners LLC dba Altus Spine

⚠️ Moderate Risk

FEI: 3009049161 • West Chester, PA • UNITED STATES

FEI

FEI Number

3009049161

📍

Location

West Chester, PA

🇺🇸
🏢

Address

1340 Enterprise Dr, , West Chester, PA, United States

Moderate Risk

FDA Import Risk Assessment

38.8
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
8/29/2024
Latest Refusal
8/29/2024
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
72.3×20%
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

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
8/29/2024
87KWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
118NOT LISTED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Altus Partners LLC dba Altus Spine's FDA import refusal history?

Altus Partners LLC dba Altus Spine (FEI: 3009049161) has 1 FDA import refusal record(s) in our database, spanning from 8/29/2024 to 8/29/2024.

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. Altus Partners LLC dba Altus Spine's FEI number is 3009049161.

What types of violations has Altus Partners LLC dba Altus Spine received?

Altus Partners LLC dba Altus Spine 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 Altus Partners LLC dba Altus Spine come from?

All FDA import refusal data for Altus Partners LLC dba Altus Spine 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.