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Avlon Industries, Inc

⚠️ Moderate Risk

FEI: 3007090726 • Melrose Park, IL • UNITED STATES

FEI

FEI Number

3007090726

📍

Location

Melrose Park, IL

🇺🇸
🏢

Address

1999 N 15th Ave, , Melrose Park, IL, United States

Moderate Risk

FDA Import Risk Assessment

35.0
LowModerateHighCritical

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

Statistics

6
Total Refusals
4
Unique Violations
11/16/2010
Latest Refusal
10/31/2008
Earliest Refusal

Score Breakdown

Violation Severity
56.7×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
29.4×10%
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

1184×

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).

32804×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

4832×

DRUG NAME

The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.

752×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
11/16/2010
53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)
118NOT LISTED
3280FRNMFGREG
Southwest Import District Office (SWI-DO)
11/16/2010
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
118NOT LISTED
3280FRNMFGREG
Southwest Import District Office (SWI-DO)
11/16/2010
53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)
118NOT LISTED
3280FRNMFGREG
Southwest Import District Office (SWI-DO)
11/16/2010
53ED05RINSES (HAIR PREPARATIONS, NON-COLORING)
118NOT LISTED
3280FRNMFGREG
Southwest Import District Office (SWI-DO)
10/31/2008
64XBY06SALICYLIC ACID (KERATOLYTIC)
483DRUG NAME
75UNAPPROVED
Florida District Office (FLA-DO)
10/31/2008
61HBY05ZINC PYRITHIONE (ANTI-BACTERIAL)
483DRUG NAME
75UNAPPROVED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Avlon Industries, Inc's FDA import refusal history?

Avlon Industries, Inc (FEI: 3007090726) has 6 FDA import refusal record(s) in our database, spanning from 10/31/2008 to 11/16/2010.

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. Avlon Industries, Inc's FEI number is 3007090726.

What types of violations has Avlon Industries, Inc received?

Avlon Industries, Inc 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 Avlon Industries, Inc come from?

All FDA import refusal data for Avlon Industries, Inc 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.