Global Electrolysis Supply
⚠️ Moderate Risk
FEI: 3004852935 • Albuquerque, NM • UNITED STATES
FEI Number
3004852935
Location
Albuquerque, NM
Country
UNITED STATESAddress
7200 Montgomery Blvd Ne, , Albuquerque, NM, United States
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
Frequently Asked Questions
What is Global Electrolysis Supply's FDA import refusal history?
Global Electrolysis Supply (FEI: 3004852935) has 2 FDA import refusal record(s) in our database, spanning from 1/4/2005 to 9/6/2005.
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. Global Electrolysis Supply's FEI number is 3004852935.
What types of violations has Global Electrolysis Supply received?
Global Electrolysis Supply has been cited for 3 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 Global Electrolysis Supply come from?
All FDA import refusal data for Global Electrolysis Supply 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.