Sterex Electrolysis Int Ltd
⚠️ Moderate Risk
FEI: 1000439607 • Birmingham • UNITED KINGDOM
FEI Number
1000439607
Location
Birmingham
Country
UNITED KINGDOMAddress
174 Kings Road, Tyseley, , Birmingham, , United Kingdom
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
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/4/2014 | 79KCWEPILATOR, HIGH FREQUENCY, NEEDLE-TYPE | 2780DEVICEGMPS | Cincinnati District Office (CIN-DO) |
| 12/6/2007 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 198COLOR LBLG | New Orleans District Office (NOL-DO) |
| 5/10/2007 | 53LY01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 197COSM COLOR | New Orleans District Office (NOL-DO) |
| 9/11/2006 | 53LG09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | 475COSMETLBLG | New Orleans District Office (NOL-DO) |
| 9/11/2006 | 53LY01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 475COSMETLBLG | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Sterex Electrolysis Int Ltd's FDA import refusal history?
Sterex Electrolysis Int Ltd (FEI: 1000439607) has 5 FDA import refusal record(s) in our database, spanning from 9/11/2006 to 2/4/2014.
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. Sterex Electrolysis Int Ltd's FEI number is 1000439607.
What types of violations has Sterex Electrolysis Int Ltd received?
Sterex Electrolysis Int Ltd has been cited for 4 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 Sterex Electrolysis Int Ltd come from?
All FDA import refusal data for Sterex Electrolysis Int 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.