Botanas Kande S.A de C.V.
⚠️ Moderate Risk
FEI: 3012747434 • Monterrey, Nuevo Leon • MEXICO
FEI Number
3012747434
Location
Monterrey, Nuevo Leon
Country
MEXICOAddress
Calle Jose Santos Chocano # 3813, Col. Fco. I. Madero, Monterrey, Monterrey, Nuevo Leon, 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 COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
YELLOW #5
The food appears to bear or contain the color additive FD & C Yellow No. 5, which is not declared on the label per 21 CFR 74.705(a)(c) under section 721.
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.
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.
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)).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/2/2024 | 33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE) | 249FILTHY | Division of Southwest Imports (DSWI) |
| 9/10/2018 | 07BGT02CORN CHIPS, FRIED | 11UNSAFE COL | Division of Southwest Imports (DSWI) |
| 8/18/2015 | 07BGB02CORN CHIPS, FRIED | 11UNSAFE COL | Southwest Import District Office (SWI-DO) |
| 10/21/2014 | 07BGT02CORN CHIPS, FRIED | Southwest Import District Office (SWI-DO) | |
| 12/13/2013 | 07BGB02CORN CHIPS, FRIED | Southwest Import District Office (SWI-DO) | |
| 7/24/2013 | 07BGT02CORN CHIPS, FRIED | Southwest Import District Office (SWI-DO) | |
| 7/24/2013 | 07BGT02CORN CHIPS, FRIED | Southwest Import District Office (SWI-DO) | |
| 9/28/2011 | 07BGT99FRIED SNACK FOODS, N.E.C. | 11UNSAFE COL | Southwest Import District Office (SWI-DO) |
| 5/19/2010 | 07BGT02CORN CHIPS, FRIED | Southwest Import District Office (SWI-DO) | |
| 8/24/2009 | 07BGN02CORN CHIPS, FRIED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Botanas Kande S.A de C.V.'s FDA import refusal history?
Botanas Kande S.A de C.V. (FEI: 3012747434) has 10 FDA import refusal record(s) in our database, spanning from 8/24/2009 to 1/2/2024.
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. Botanas Kande S.A de C.V.'s FEI number is 3012747434.
What types of violations has Botanas Kande S.A de C.V. received?
Botanas Kande S.A de C.V. has been cited for 6 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 Botanas Kande S.A de C.V. come from?
All FDA import refusal data for Botanas Kande 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.