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Shopbras Comercio E Disribuicao Ltd

⚠️ Moderate Risk

FEI: 3010139394 • Guarulhos, Sp • BRAZIL

FEI

FEI Number

3010139394

📍

Location

Guarulhos, Sp

🇧🇷

Country

BRAZIL
🏢

Address

Sala 503 R Barao De Maua 450, , Guarulhos, Sp, Brazil

Moderate Risk

FDA Import Risk Assessment

36.6
LowModerateHighCritical

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

Statistics

16
Total Refusals
9
Unique Violations
3/14/2016
Latest Refusal
9/17/2013
Earliest Refusal

Score Breakdown

Violation Severity
41.3×40%
Refusal Volume
45.6×30%
Recency
0.0×20%
Frequency
64.3×10%
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

47511×

COSMETLBLG

It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.

47311×

LABELING

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

47410×

COSMETLBLG

It appears the label does not bear the common or usual name of the cosmetic.

47110×

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.

2184×

LIST INGRE

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(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

3243×

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)).

4822×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

2381×

UNSAFE ADD

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.

1971×

COSM COLOR

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).

Refusal History

DateProductViolationsDivision
3/14/2016
53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
197COSM COLOR
473LABELING
475COSMETLBLG
Division of Northeast Imports (DNEI)
2/4/2016
53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
473LABELING
474COSMETLBLG
475COSMETLBLG
Division of Northeast Imports (DNEI)
2/4/2016
53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
473LABELING
474COSMETLBLG
475COSMETLBLG
Division of Northeast Imports (DNEI)
2/4/2016
53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
473LABELING
474COSMETLBLG
475COSMETLBLG
Division of Northeast Imports (DNEI)
2/4/2016
53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
473LABELING
474COSMETLBLG
475COSMETLBLG
Division of Northeast Imports (DNEI)
2/4/2016
53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
473LABELING
474COSMETLBLG
475COSMETLBLG
Division of Northeast Imports (DNEI)
2/4/2016
53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
473LABELING
474COSMETLBLG
475COSMETLBLG
Division of Northeast Imports (DNEI)
2/4/2016
53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
473LABELING
474COSMETLBLG
475COSMETLBLG
Division of Northeast Imports (DNEI)
2/4/2016
53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
473LABELING
474COSMETLBLG
475COSMETLBLG
Division of Northeast Imports (DNEI)
2/4/2016
53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
473LABELING
474COSMETLBLG
475COSMETLBLG
Division of Northeast Imports (DNEI)
2/4/2016
53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
473LABELING
474COSMETLBLG
475COSMETLBLG
Division of Northeast Imports (DNEI)
2/4/2016
33EGT11MINT CANDY, HARD, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
238UNSAFE ADD
Division of Northeast Imports (DNEI)
2/4/2016
03JGT07MIXED FILLED/ICED COOKIES,BISCUITS AND WAFERS
218LIST INGRE
324NO ENGLISH
482NUTRIT LBL
Division of Northeast Imports (DNEI)
2/4/2016
31LGT30TEA, INSTANT, PLAIN, DECAFFEINATED
218LIST INGRE
324NO ENGLISH
Division of Northeast Imports (DNEI)
2/4/2016
31LGT30TEA, INSTANT, PLAIN, DECAFFEINATED
218LIST INGRE
324NO ENGLISH
Division of Northeast Imports (DNEI)
9/17/2013
03FGT06SALTED CRACKERS
218LIST INGRE
482NUTRIT LBL
New York District Office (NYK-DO)

Frequently Asked Questions

What is Shopbras Comercio E Disribuicao Ltd's FDA import refusal history?

Shopbras Comercio E Disribuicao Ltd (FEI: 3010139394) has 16 FDA import refusal record(s) in our database, spanning from 9/17/2013 to 3/14/2016.

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. Shopbras Comercio E Disribuicao Ltd's FEI number is 3010139394.

What types of violations has Shopbras Comercio E Disribuicao Ltd received?

Shopbras Comercio E Disribuicao Ltd has been cited for 9 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 Shopbras Comercio E Disribuicao Ltd come from?

All FDA import refusal data for Shopbras Comercio E Disribuicao Ltd 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.