COMESTIBLES LA ROSA SA

⚠️ Moderate Risk

FEI: 3012243445 • Dosquebradas, Risaralda • COLOMBIA

FEI

FEI Number

3012243445

📍

Location

Dosquebradas, Risaralda

🇨🇴

Country

COLOMBIA

🏢

Address

Calle 29 #10 215, , Dosquebradas, Risaralda, Colombia

Moderate Risk

FDA Import Risk Assessment

29.4

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

6/26/2018

Latest Refusal

6/26/2018

Earliest Refusal

Score Breakdown

Violation Severity

35.0×40%

Refusal Volume

31.3×30%

Recency

0.0×20%

Frequency

60.0×10%

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

Violation Summary

3246×

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)).

4736×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

Refusal History

Date	Product	Violations	Division
6/26/2018	03JGT10CREME FILLED/ICED COOKIE,BISCUIT,WAFER	324NO ENGLISH 473LABELING	Division of Southeast Imports (DSEI)
6/26/2018	03MGT99COOKIE,BISCUIT,WAFER DOUGH, N.E.C.	324NO ENGLISH 473LABELING	Division of Southeast Imports (DSEI)
6/26/2018	03JGT10CREME FILLED/ICED COOKIE,BISCUIT,WAFER	324NO ENGLISH 473LABELING	Division of Southeast Imports (DSEI)
6/26/2018	03MGT99COOKIE,BISCUIT,WAFER DOUGH, N.E.C.	324NO ENGLISH 473LABELING	Division of Southeast Imports (DSEI)
6/26/2018	03MGT99COOKIE,BISCUIT,WAFER DOUGH, N.E.C.	324NO ENGLISH 473LABELING	Division of Southeast Imports (DSEI)
6/26/2018	03MGT99COOKIE,BISCUIT,WAFER DOUGH, N.E.C.	324NO ENGLISH 473LABELING	Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is COMESTIBLES LA ROSA SA's FDA import refusal history?

COMESTIBLES LA ROSA SA (FEI: 3012243445) has 6 FDA import refusal record(s) in our database, spanning from 6/26/2018 to 6/26/2018.

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. COMESTIBLES LA ROSA SA's FEI number is 3012243445.

What types of violations has COMESTIBLES LA ROSA SA received?

COMESTIBLES LA ROSA SA 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 COMESTIBLES LA ROSA SA come from?

All FDA import refusal data for COMESTIBLES LA ROSA SA 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.