Alessandro
⚠️ Moderate Risk
FEI: 3003466847 • Langenfeld (Rheinland) • GERMANY
FEI Number
3003466847
Location
Langenfeld (Rheinland)
Country
GERMANYAddress
Hans Bockler Str 42, , Langenfeld (Rheinland), , Germany
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
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).
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/27/2004 | 53HD06NAIL POLISH AND ENAMEL REMOVERS (MANICURING PREPARATIONS) | 197COSM COLOR | New York District Office (NYK-DO) |
| 10/27/2004 | 53HC03NAIL CREAMS AND LOTIONS (MANICURING PREPARATIONS) | 197COSM COLOR | New York District Office (NYK-DO) |
| 9/2/2003 | 62FBJ23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Alessandro's FDA import refusal history?
Alessandro (FEI: 3003466847) has 3 FDA import refusal record(s) in our database, spanning from 9/2/2003 to 10/27/2004.
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. Alessandro's FEI number is 3003466847.
What types of violations has Alessandro received?
Alessandro 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 Alessandro come from?
All FDA import refusal data for Alessandro 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.