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Spellman Hg Vltg Elctrnc

⚠️ Moderate Risk

FEI: 2429877 • Hauppauge, NY • UNITED STATES

FEI

FEI Number

2429877

📍

Location

Hauppauge, NY

🇺🇸
🏢

Address

475 Wireless Blvd, , Hauppauge, NY, United States

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

2
Total Refusals
1
Unique Violations
3/5/2013
Latest Refusal
8/22/2008
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
4.4×10%
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

472×

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
3/5/2013
90IZOGENERATOR, HIGH-VOLTAGE, X-RAY, DIAGNOSTIC
47NON STD
Florida District Office (FLA-DO)
8/22/2008
90IYBTUBE MOUNT, X-RAY, DIAGNOSTIC
47NON STD
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Spellman Hg Vltg Elctrnc's FDA import refusal history?

Spellman Hg Vltg Elctrnc (FEI: 2429877) has 2 FDA import refusal record(s) in our database, spanning from 8/22/2008 to 3/5/2013.

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. Spellman Hg Vltg Elctrnc's FEI number is 2429877.

What types of violations has Spellman Hg Vltg Elctrnc received?

Spellman Hg Vltg Elctrnc 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 Spellman Hg Vltg Elctrnc come from?

All FDA import refusal data for Spellman Hg Vltg Elctrnc 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.