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ENVASADORA GUGAR, S.A. DE C.V.

⚠️ Moderate Risk

FEI: 3002853463 • Fracc. Tlalixtac De Cabrera, Oaxaca • MEXICO

FEI

FEI Number

3002853463

📍

Location

Fracc. Tlalixtac De Cabrera, Oaxaca

🇲🇽

Country

MEXICO
🏢

Address

Calle Camino De La Toma No. 108, Tlalixtac De Cabrera, Fracc. Tlalixtac De Cabrera, Oaxaca, Mexico

Moderate Risk

FDA Import Risk Assessment

27.6
LowModerateHighCritical

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

Statistics

8
Total Refusals
11
Unique Violations
5/14/2018
Latest Refusal
6/3/2010
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
35.3×30%
Recency
0.0×20%
Frequency
10.1×10%
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

3206×

LACKS FIRM

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(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.

2746×

COLOR LBLG

The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.

38655×

COLORLABEL

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.

2185×

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.

3215×

LACKS N/C

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(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.

3245×

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)).

3285×

USUAL NAME

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)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be.

113×

UNSAFE COL

The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).

2601×

FALSE

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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

2561×

INCONSPICU

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)).

2491×

FILTHY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.

Refusal History

DateProductViolationsDivision
5/14/2018
29AGO06SOFT DRINK, IMITATION FRUIT FLAVORED, NONCARBONATED
11UNSAFE COL
320LACKS FIRM
Division of Southwest Imports (DSWI)
6/22/2017
29AGO07SOFT DRINK, SUBTROPICAL OR TROPICAL FRUIT FLAVORED, NONCARBONATED
218LIST INGRE
274COLOR LBLG
320LACKS FIRM
321LACKS N/C
324NO ENGLISH
328USUAL NAME
3865COLORLABEL
Division of Southwest Imports (DSWI)
6/22/2017
29AGO07SOFT DRINK, SUBTROPICAL OR TROPICAL FRUIT FLAVORED, NONCARBONATED
218LIST INGRE
274COLOR LBLG
320LACKS FIRM
321LACKS N/C
324NO ENGLISH
328USUAL NAME
3865COLORLABEL
Division of Southwest Imports (DSWI)
6/22/2017
29AGO07SOFT DRINK, SUBTROPICAL OR TROPICAL FRUIT FLAVORED, NONCARBONATED
218LIST INGRE
274COLOR LBLG
320LACKS FIRM
321LACKS N/C
324NO ENGLISH
328USUAL NAME
3865COLORLABEL
Division of Southwest Imports (DSWI)
6/22/2017
29AGO07SOFT DRINK, SUBTROPICAL OR TROPICAL FRUIT FLAVORED, NONCARBONATED
218LIST INGRE
274COLOR LBLG
320LACKS FIRM
321LACKS N/C
324NO ENGLISH
328USUAL NAME
3865COLORLABEL
Division of Southwest Imports (DSWI)
6/22/2017
29AGO07SOFT DRINK, SUBTROPICAL OR TROPICAL FRUIT FLAVORED, NONCARBONATED
11UNSAFE COL
218LIST INGRE
274COLOR LBLG
320LACKS FIRM
321LACKS N/C
324NO ENGLISH
328USUAL NAME
3865COLORLABEL
Division of Southwest Imports (DSWI)
4/30/2013
29AGO06SOFT DRINK, IMITATION FRUIT FLAVORED, NONCARBONATED
11UNSAFE COL
256INCONSPICU
260FALSE
274COLOR LBLG
Southwest Import District Office (SWI-DO)
6/3/2010
29BCY99CARBONATED SOFT DRINK, N.E.C.
249FILTHY
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is ENVASADORA GUGAR, S.A. DE C.V.'s FDA import refusal history?

ENVASADORA GUGAR, S.A. DE C.V. (FEI: 3002853463) has 8 FDA import refusal record(s) in our database, spanning from 6/3/2010 to 5/14/2018.

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. ENVASADORA GUGAR, S.A. DE C.V.'s FEI number is 3002853463.

What types of violations has ENVASADORA GUGAR, S.A. DE C.V. received?

ENVASADORA GUGAR, S.A. DE C.V. has been cited for 11 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 ENVASADORA GUGAR, S.A. DE C.V. come from?

All FDA import refusal data for ENVASADORA GUGAR, S.A. DE C.V. 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.