Embotelladora Bebidas Mundiales s.a. de c.v.
⚠️ Moderate Risk
FEI: 3011636744 • Zapopan, Jalisco • MEXICO
FEI Number
3011636744
Location
Zapopan, Jalisco
Country
MEXICOAddress
Avenida San Isidro 580, San Jose Del Bajio, Zapopan, Zapopan, Jalisco, Mexico
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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.
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)).
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.
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.
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.
FSVP VIO
The article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) in that it appears that the importer (as defined in section 805 of the FD&C Act) is in violation of section 805.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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)).
JUICE %
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 the food purports to be a beverage containing vegetable or fruit juice and does not bear a statement on the label in appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained therein.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/17/2022 | 29BCT50SOFT DRINK, COLA, CARBONATED | 3886FSVP VIO | Division of Southwest Imports (DSWI) |
| 3/17/2022 | 29BCT02SOFT DRINK, CITRUS FRUIT FLAVORED, CARBONATED | 3886FSVP VIO | Division of Southwest Imports (DSWI) |
| 3/17/2022 | 29BCT03SOFT DRINK, CORE FRUIT FLAVORED, CARBONATED | 3886FSVP VIO | Division of Southwest Imports (DSWI) |
| 7/9/2019 | 29BCT02SOFT DRINK, CITRUS FRUIT FLAVORED, CARBONATED | Division of Southwest Imports (DSWI) | |
| 7/9/2019 | 29BCT02SOFT DRINK, CITRUS FRUIT FLAVORED, CARBONATED | Division of Southwest Imports (DSWI) | |
| 7/9/2019 | 29BCT02SOFT DRINK, CITRUS FRUIT FLAVORED, CARBONATED | Division of Southwest Imports (DSWI) | |
| 2/25/2019 | 29BCT02SOFT DRINK, CITRUS FRUIT FLAVORED, CARBONATED | Division of Southwest Imports (DSWI) | |
| 2/25/2019 | 29BCT02SOFT DRINK, CITRUS FRUIT FLAVORED, CARBONATED | Division of Southwest Imports (DSWI) | |
| 3/26/2018 | 29BCT02SOFT DRINK, CITRUS FRUIT FLAVORED, CARBONATED | Division of Southwest Imports (DSWI) | |
| 2/26/2018 | 29BGT02SOFT DRINK, CITRUS FRUIT FLAVORED, CARBONATED | Division of Southwest Imports (DSWI) | |
| 6/1/2016 | 29BCE02SOFT DRINK, CITRUS FRUIT FLAVORED, CARBONATED | Division of Southwest Imports (DSWI) | |
| 3/9/2016 | 29BCE02SOFT DRINK, CITRUS FRUIT FLAVORED, CARBONATED | Southwest Import District Office (SWI-DO) | |
| 3/3/2016 | 29BCE02SOFT DRINK, CITRUS FRUIT FLAVORED, CARBONATED | 238UNSAFE ADD | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Embotelladora Bebidas Mundiales s.a. de c.v.'s FDA import refusal history?
Embotelladora Bebidas Mundiales s.a. de c.v. (FEI: 3011636744) has 13 FDA import refusal record(s) in our database, spanning from 3/3/2016 to 3/17/2022.
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. Embotelladora Bebidas Mundiales s.a. de c.v.'s FEI number is 3011636744.
What types of violations has Embotelladora Bebidas Mundiales s.a. de c.v. received?
Embotelladora Bebidas Mundiales s.a. de c.v. has been cited for 10 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 Embotelladora Bebidas Mundiales s.a. de c.v. come from?
All FDA import refusal data for Embotelladora Bebidas Mundiales 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.