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ASO LLC

⚠️ High Risk

FEI: 1038758 • Sarasota, FL • UNITED STATES

FEI

FEI Number

1038758

📍

Location

Sarasota, FL

🇺🇸
🏢

Address

300 Sarasota Center Blvd, , Sarasota, FL, United States

High Risk

FDA Import Risk Assessment

56.1
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

9
Total Refusals
1
Unique Violations
7/8/2014
Latest Refusal
7/8/2014
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
37.0×30%
Recency
0.0×20%
Frequency
90.0×10%
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

789×

STERILITY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.

Refusal History

DateProductViolationsDivision
7/8/2014
79KGXTAPE AND BANDAGE, ADHESIVE
78STERILITY
Southwest Import District Office (SWI-DO)
7/8/2014
79KGXTAPE AND BANDAGE, ADHESIVE
78STERILITY
Southwest Import District Office (SWI-DO)
7/8/2014
79KGXTAPE AND BANDAGE, ADHESIVE
78STERILITY
Southwest Import District Office (SWI-DO)
7/8/2014
79KGXTAPE AND BANDAGE, ADHESIVE
78STERILITY
Southwest Import District Office (SWI-DO)
7/8/2014
79KGXTAPE AND BANDAGE, ADHESIVE
78STERILITY
Southwest Import District Office (SWI-DO)
7/8/2014
79KGXTAPE AND BANDAGE, ADHESIVE
78STERILITY
Southwest Import District Office (SWI-DO)
7/8/2014
79KGXTAPE AND BANDAGE, ADHESIVE
78STERILITY
Southwest Import District Office (SWI-DO)
7/8/2014
79KGXTAPE AND BANDAGE, ADHESIVE
78STERILITY
Southwest Import District Office (SWI-DO)
7/8/2014
79KGXTAPE AND BANDAGE, ADHESIVE
78STERILITY
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is ASO LLC's FDA import refusal history?

ASO LLC (FEI: 1038758) has 9 FDA import refusal record(s) in our database, spanning from 7/8/2014 to 7/8/2014.

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. ASO LLC's FEI number is 1038758.

What types of violations has ASO LLC received?

ASO LLC 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 ASO LLC come from?

All FDA import refusal data for ASO LLC 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.