Embotelladora Arca S.A. De C.V.
⚠️ Moderate Risk
FEI: 3004200829 • Monterrey • 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).
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.
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.
DIETARY
The article purports to be or is represented for special dietary uses and its label does not appear to bear the nutritional information required by regulation.
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.
WRONG IDEN
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 as defined in section 403(b) of the FD&C Act. The article appears to be offered for sale under the name of another food.
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.
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)).
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)).
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 |
|---|---|---|---|
| 4/11/2011 | 29BCT09SOFT DRINK, OTHER FRUIT FLAVORED, CARBONATED | 11UNSAFE COL | Southwest Import District Office (SWI-DO) |
| 3/22/2011 | 29BCT03SOFT DRINK, CORE FRUIT FLAVORED, CARBONATED | Southwest Import District Office (SWI-DO) | |
| 2/22/2011 | 29BCY04SOFT DRINK, MIXED FRUIT FLAVORED, CARBONATED | 11UNSAFE COL | Southwest Import District Office (SWI-DO) |
| 12/3/2010 | 29BCT07SOFT DRINK, SUBTROPICAL OR TROPICAL FRUIT FLAVORED, CARBONATED | Southwest Import District Office (SWI-DO) | |
| 7/26/2010 | 29BCT02SOFT DRINK, CITRUS FRUIT FLAVORED, CARBONATED | Southwest Import District Office (SWI-DO) | |
| 3/4/2010 | 29BHT06SOFT DRINK, IMITATION FRUIT FLAVORED, CARBONATED | 11UNSAFE COL | Southwest Import District Office (SWI-DO) |
| 3/4/2010 | 29BCT03SOFT DRINK, CORE FRUIT FLAVORED, CARBONATED | 11UNSAFE COL | Southwest Import District Office (SWI-DO) |
| 7/31/2009 | 29BCT03SOFT DRINK, CORE FRUIT FLAVORED, CARBONATED | Southwest Import District Office (SWI-DO) | |
| 11/7/2006 | 29BGT50SOFT DRINK, COLA, CARBONATED | 324NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 6/4/2004 | 29BCT50SOFT DRINK, COLA, CARBONATED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Embotelladora Arca S.A. De C.V.'s FDA import refusal history?
Embotelladora Arca S.A. De C.V. (FEI: 3004200829) has 10 FDA import refusal record(s) in our database, spanning from 6/4/2004 to 4/11/2011.
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 Arca S.A. De C.V.'s FEI number is 3004200829.
What types of violations has Embotelladora Arca S.A. De C.V. received?
Embotelladora Arca 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 Embotelladora Arca S.A. De C.V. come from?
All FDA import refusal data for Embotelladora Arca 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.