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ECONOMICA, SOCIEDAD ANONIMA

⚠️ Moderate Risk

FEI: 3014150170 • Huehuetenango, Huehuetenango • GUATEMALA

FEI

FEI Number

3014150170

📍

Location

Huehuetenango, Huehuetenango

🇬🇹

Country

GUATEMALA
🏢

Address

Calle Canton Saboj Sanrafael, La Independencia, , Huehuetenango, Huehuetenango, Guatemala

Moderate Risk

FDA Import Risk Assessment

33.6
LowModerateHighCritical

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

Statistics

7
Total Refusals
3
Unique Violations
9/6/2019
Latest Refusal
9/6/2019
Earliest Refusal

Score Breakdown

Violation Severity
41.4×40%
Refusal Volume
33.5×30%
Recency
0.0×20%
Frequency
70.0×10%
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

4714×

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.

32802×

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.

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

Refusal History

DateProductViolationsDivision
9/6/2019
61HBY99ANTI-BACTERIAL, N.E.C.
3280FRNMFGREG
Division of Southeast Imports (DSEI)
9/6/2019
61HBY99ANTI-BACTERIAL, N.E.C.
3280FRNMFGREG
Division of Southeast Imports (DSEI)
9/6/2019
61HBY99ANTI-BACTERIAL, N.E.C.
472NO ENGLISH
Division of Southeast Imports (DSEI)
9/6/2019
53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
Division of Southeast Imports (DSEI)
9/6/2019
53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
Division of Southeast Imports (DSEI)
9/6/2019
53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
Division of Southeast Imports (DSEI)
9/6/2019
53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)
471CSTIC LBLG
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is ECONOMICA, SOCIEDAD ANONIMA's FDA import refusal history?

ECONOMICA, SOCIEDAD ANONIMA (FEI: 3014150170) has 7 FDA import refusal record(s) in our database, spanning from 9/6/2019 to 9/6/2019.

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. ECONOMICA, SOCIEDAD ANONIMA's FEI number is 3014150170.

What types of violations has ECONOMICA, SOCIEDAD ANONIMA received?

ECONOMICA, SOCIEDAD ANONIMA 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 ECONOMICA, SOCIEDAD ANONIMA come from?

All FDA import refusal data for ECONOMICA, SOCIEDAD ANONIMA 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.