ImportRefusal LogoImportRefusal

FABRICA COMESTIBLES LA ROSA S.A.

Low Risk

FEI: 3004249829 • DOSQUEBRADAS, CO-RIS • COLOMBIA

FEI

FEI Number

3004249829

📍

Location

DOSQUEBRADAS, CO-RIS

🇨🇴

Country

COLOMBIA
🏢

Address

Calle 29 # 10-215, , DOSQUEBRADAS, CO-RIS, Colombia

Low Risk

FDA Import Risk Assessment

16.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
8/1/2018
Latest Refusal
8/1/2018
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

3241×

NO ENGLISH

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).

Refusal History

DateProductViolationsDivision
8/1/2018
34FYY04CHOCOLATE COVERED CANDY PIECES, WITHOUT NUTS AND FRUIT
324NO ENGLISH
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is FABRICA COMESTIBLES LA ROSA S.A.'s FDA import refusal history?

FABRICA COMESTIBLES LA ROSA S.A. (FEI: 3004249829) has 1 FDA import refusal record(s) in our database, spanning from 8/1/2018 to 8/1/2018.

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. FABRICA COMESTIBLES LA ROSA S.A.'s FEI number is 3004249829.

What types of violations has FABRICA COMESTIBLES LA ROSA S.A. received?

FABRICA COMESTIBLES LA ROSA S.A. has been cited for 1 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 FABRICA COMESTIBLES LA ROSA S.A. come from?

All FDA import refusal data for FABRICA COMESTIBLES LA ROSA S.A. 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.