Danone de Mexico S.A. de C.V.
⚠️ Moderate Risk
FEI: 3004954512 • Santa Fe, Distrito Federal • MEXICO
FEI Number
3004954512
Location
Santa Fe, Distrito Federal
Country
MEXICOAddress
Guillermo Gonzalex Camarena No. 333, Colcentro Cd., Santa Fe, Distrito Federal, 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
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.
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)).
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.
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.
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).
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)).
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.
PRESRV LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a chemical preservative and it fails to bear labeling stating that fact including its function.
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/16/2009 | 09CGT15YOGURT (PLAIN, FLAVORED OR FRUIT ADDED) | Southwest Import District Office (SWI-DO) | |
| 5/20/2009 | 09CGT15YOGURT (PLAIN, FLAVORED OR FRUIT ADDED) | 218LIST INGRE | Southwest Import District Office (SWI-DO) |
| 5/12/2009 | 09CGT15YOGURT (PLAIN, FLAVORED OR FRUIT ADDED) | Southwest Import District Office (SWI-DO) | |
| 2/12/2009 | 09CGT15YOGURT (PLAIN, FLAVORED OR FRUIT ADDED) | Southwest Import District Office (SWI-DO) | |
| 2/12/2009 | 09CGT15YOGURT (PLAIN, FLAVORED OR FRUIT ADDED) | Southwest Import District Office (SWI-DO) | |
| 2/10/2009 | 09CGT15YOGURT (PLAIN, FLAVORED OR FRUIT ADDED) | Southwest Import District Office (SWI-DO) | |
| 1/30/2009 | 09CGT15YOGURT (PLAIN, FLAVORED OR FRUIT ADDED) | Southwest Import District Office (SWI-DO) | |
| 1/2/2009 | 09CGT15YOGURT (PLAIN, FLAVORED OR FRUIT ADDED) | Southwest Import District Office (SWI-DO) | |
| 12/9/2008 | 09CGT15YOGURT (PLAIN, FLAVORED OR FRUIT ADDED) | Southwest Import District Office (SWI-DO) | |
| 11/18/2008 | 09CGT15YOGURT (PLAIN, FLAVORED OR FRUIT ADDED) | Southwest Import District Office (SWI-DO) | |
| 10/18/2007 | 09EGO15YOGURT (PLAIN, FLAVORED AND FRUIT ADDED), NON FAT | Southwest Import District Office (SWI-DO) | |
| 8/24/2007 | 09EGO15YOGURT (PLAIN, FLAVORED AND FRUIT ADDED), NON FAT | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Danone de Mexico S.A. de C.V.'s FDA import refusal history?
Danone de Mexico S.A. de C.V. (FEI: 3004954512) has 12 FDA import refusal record(s) in our database, spanning from 8/24/2007 to 11/16/2009.
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. Danone de Mexico S.A. de C.V.'s FEI number is 3004954512.
What types of violations has Danone de Mexico S.A. de C.V. received?
Danone de Mexico 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 Danone de Mexico S.A. de C.V. come from?
All FDA import refusal data for Danone de Mexico 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.