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ARTESAL-EXPORT

⚠️ Moderate Risk

FEI: 3007474994 • Soyapango, San Salvador • EL SALVADOR

FEI

FEI Number

3007474994

📍

Location

Soyapango, San Salvador

🇸🇻
🏢

Address

Urb. Los Conocastes, Pje 2 Ote, , Soyapango, San Salvador, El Salvador

Moderate Risk

FDA Import Risk Assessment

33.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
3/18/2011
Latest Refusal
3/18/2011
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

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.

751×

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
3/18/2011
53EC01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
Los Angeles District Office (LOS-DO)
3/18/2011
62GBJ99ANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is ARTESAL-EXPORT's FDA import refusal history?

ARTESAL-EXPORT (FEI: 3007474994) has 2 FDA import refusal record(s) in our database, spanning from 3/18/2011 to 3/18/2011.

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. ARTESAL-EXPORT's FEI number is 3007474994.

What types of violations has ARTESAL-EXPORT received?

ARTESAL-EXPORT has been cited for 2 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 ARTESAL-EXPORT come from?

All FDA import refusal data for ARTESAL-EXPORT 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.