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Thermo Fisher Scientific (Asheville) LLC

⚠️ Moderate Risk

FEI: 1036832 • Asheville, NC • UNITED STATES

FEI

FEI Number

1036832

📍

Location

Asheville, NC

🇺🇸
🏢

Address

275 Aiken Rd, , Asheville, NC, United States

Moderate Risk

FDA Import Risk Assessment

31.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
8/31/2005
Latest Refusal
5/9/2005
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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).

471×

NON STD

The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.

Refusal History

DateProductViolationsDivision
8/31/2005
94C08COLD-CATHODE GAS DISCHARGE TUBE FOR NON-MEDICAL USE
47NON STD
New York District Office (NYK-DO)
5/9/2005
75JQCCENTRIFUGES (MICRO, ULTRA, REFRIGERATED) FOR CLINICAL USE
118NOT LISTED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Thermo Fisher Scientific (Asheville) LLC's FDA import refusal history?

Thermo Fisher Scientific (Asheville) LLC (FEI: 1036832) has 2 FDA import refusal record(s) in our database, spanning from 5/9/2005 to 8/31/2005.

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. Thermo Fisher Scientific (Asheville) LLC's FEI number is 1036832.

What types of violations has Thermo Fisher Scientific (Asheville) LLC received?

Thermo Fisher Scientific (Asheville) LLC has been cited for 2 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 Thermo Fisher Scientific (Asheville) LLC come from?

All FDA import refusal data for Thermo Fisher Scientific (Asheville) 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.