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ASM Aerosol Service AG

⚠️ Moderate Risk

FEI: 3005439256 • Mohlin, Aargau • SWITZERLAND

FEI

FEI Number

3005439256

📍

Location

Mohlin, Aargau

🇨🇭
🏢

Address

Industriestrasse 11, , Mohlin, Aargau, Switzerland

Moderate Risk

FDA Import Risk Assessment

32.1
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
8/8/2018
Latest Refusal
10/7/2002
Earliest Refusal

Score Breakdown

Violation Severity
66.7×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
1.3×10%
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

161×

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.

2921×

SUBSTITUTE

It appears to be a drug that a substance has been substituted wholly or in part.

4711×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

Refusal History

DateProductViolationsDivision
8/8/2018
56EIQ61MINOCYCLINE HYDROCHLORIDE (TETRACYCLINES)
16DIRECTIONS
292SUBSTITUTE
Division of Northern Border Imports (DNBI)
10/7/2002
53DY99OTHER FRAGRANCE PREPARATIONS, N.E.C.
471CSTIC LBLG
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is ASM Aerosol Service AG's FDA import refusal history?

ASM Aerosol Service AG (FEI: 3005439256) has 2 FDA import refusal record(s) in our database, spanning from 10/7/2002 to 8/8/2018.

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. ASM Aerosol Service AG's FEI number is 3005439256.

What types of violations has ASM Aerosol Service AG received?

ASM Aerosol Service AG 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 ASM Aerosol Service AG come from?

All FDA import refusal data for ASM Aerosol Service AG 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.