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Sigma-Aldrich Company Ltd

⚠️ Moderate Risk

FEI: 3001022147 • Poole, Dorset • UNITED KINGDOM

FEI

FEI Number

3001022147

📍

Location

Poole, Dorset

🇬🇧
🏢

Address

Fancy Road, , Poole, Dorset, United Kingdom

Moderate Risk

FDA Import Risk Assessment

33.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
9/7/2018
Latest Refusal
9/7/2018
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

2233×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

Refusal History

DateProductViolationsDivision
9/7/2018
57VH99IN-VITRO DIAG PRODUCTS, N.E.C.
223FALSE
Division of Southeast Imports (DSEI)
9/7/2018
88OTURESEARCH USE ONLY/PATHOLOGY
223FALSE
Division of Southeast Imports (DSEI)
9/7/2018
55RP99PHARMACEUTIC NECESSITIES, N.E.C.
223FALSE
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Sigma-Aldrich Company Ltd's FDA import refusal history?

Sigma-Aldrich Company Ltd (FEI: 3001022147) has 3 FDA import refusal record(s) in our database, spanning from 9/7/2018 to 9/7/2018.

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. Sigma-Aldrich Company Ltd's FEI number is 3001022147.

What types of violations has Sigma-Aldrich Company Ltd received?

Sigma-Aldrich Company Ltd 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 Sigma-Aldrich Company Ltd come from?

All FDA import refusal data for Sigma-Aldrich Company Ltd 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.