ENVASADORA LA SUPREMA SA DE CV
⚠️ Moderate Risk
FEI: 3010739593 • Ciudad De Mexico, Ciudad de Mexico • MEXICO
FEI Number
3010739593
Location
Ciudad De Mexico, Ciudad de Mexico
Country
MEXICOAddress
Mario Pani 150, Col. Santa Fe Cuajimalpa, Cuajimalpa De Morelos, Ciudad De Mexico, Ciudad de Mexico, 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
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.
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.
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
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).
UNSAFE COL
The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/22/2016 | 29BGT60SODA WATER, CARBONATED | 324NO ENGLISH | Division of Northeast Imports (DNEI) |
| 8/11/2015 | 29RGT02BOTTLED SPRING WATER WITH FRUIT FLAVORS, NONCARBONATED (NONMEDICINAL) | Southwest Import District Office (SWI-DO) | |
| 8/11/2015 | 29RGT02BOTTLED SPRING WATER WITH FRUIT FLAVORS, NONCARBONATED (NONMEDICINAL) | Southwest Import District Office (SWI-DO) | |
| 8/11/2015 | 29RGT02BOTTLED SPRING WATER WITH FRUIT FLAVORS, NONCARBONATED (NONMEDICINAL) | Southwest Import District Office (SWI-DO) | |
| 8/11/2015 | 29RGT02BOTTLED SPRING WATER WITH FRUIT FLAVORS, NONCARBONATED (NONMEDICINAL) | Southwest Import District Office (SWI-DO) | |
| 8/11/2015 | 29RGT02BOTTLED SPRING WATER WITH FRUIT FLAVORS, NONCARBONATED (NONMEDICINAL) | Southwest Import District Office (SWI-DO) | |
| 5/5/2015 | 29RHY04BOTTLED WATER WITH FRUIT FLAVORS, NONCARBONATED (NONMEDICINAL) | Southwest Import District Office (SWI-DO) | |
| 5/5/2015 | 29RHY04BOTTLED WATER WITH FRUIT FLAVORS, NONCARBONATED (NONMEDICINAL) | Southwest Import District Office (SWI-DO) | |
| 5/5/2015 | 29RHY04BOTTLED WATER WITH FRUIT FLAVORS, NONCARBONATED (NONMEDICINAL) | Southwest Import District Office (SWI-DO) | |
| 5/5/2015 | 29RHY04BOTTLED WATER WITH FRUIT FLAVORS, NONCARBONATED (NONMEDICINAL) | Southwest Import District Office (SWI-DO) | |
| 5/5/2015 | 29RHY04BOTTLED WATER WITH FRUIT FLAVORS, NONCARBONATED (NONMEDICINAL) | Southwest Import District Office (SWI-DO) | |
| 5/5/2015 | 29RHY04BOTTLED WATER WITH FRUIT FLAVORS, NONCARBONATED (NONMEDICINAL) | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is ENVASADORA LA SUPREMA SA DE CV's FDA import refusal history?
ENVASADORA LA SUPREMA SA DE CV (FEI: 3010739593) has 12 FDA import refusal record(s) in our database, spanning from 5/5/2015 to 7/22/2016.
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. ENVASADORA LA SUPREMA SA DE CV's FEI number is 3010739593.
What types of violations has ENVASADORA LA SUPREMA SA DE CV received?
ENVASADORA LA SUPREMA SA DE CV has been cited for 8 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 LA SUPREMA SA DE CV come from?
All FDA import refusal data for ENVASADORA LA SUPREMA SA DE CV 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.