Embotelladora Nacional S.A.
⚠️ Moderate Risk
FEI: 3010120277 • Managua, NI-MN • NICARAGUA
FEI Number
3010120277
Location
Managua, NI-MN
Country
NICARAGUAAddress
KM 7.5 Carretera Norte Detras De Niimac, , Managua, NI-MN, Nicaragua
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
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)).
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.
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.
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 |
|---|---|---|---|
| 2/9/2024 | 29BGT07SOFT DRINK, SUBTROPICAL OR TROPICAL FRUIT FLAVORED, CARBONATED | Division of Southeast Imports (DSEI) | |
| 2/8/2019 | 29BCT07SOFT DRINK, SUBTROPICAL OR TROPICAL FRUIT FLAVORED, CARBONATED | 11UNSAFE COL | Division of Southeast Imports (DSEI) |
| 8/2/2016 | 29BCT02SOFT DRINK, CITRUS FRUIT FLAVORED, CARBONATED | 11UNSAFE COL | Florida District Office (FLA-DO) |
| 6/21/2011 | 29BCT09SOFT DRINK, OTHER FRUIT FLAVORED, CARBONATED | Florida District Office (FLA-DO) | |
| 1/12/2011 | 29BCT07SOFT DRINK, SUBTROPICAL OR TROPICAL FRUIT FLAVORED, CARBONATED | 11UNSAFE COL | Division of Southeast Imports (DSEI) |
| 7/30/2010 | 29BCT50SOFT DRINK, COLA, CARBONATED | 324NO ENGLISH | Division of Southeast Imports (DSEI) |
| 7/30/2010 | 29BCT07SOFT DRINK, SUBTROPICAL OR TROPICAL FRUIT FLAVORED, CARBONATED | 324NO ENGLISH | Division of Southeast Imports (DSEI) |
| 7/30/2010 | 29BCT07SOFT DRINK, SUBTROPICAL OR TROPICAL FRUIT FLAVORED, CARBONATED | 324NO ENGLISH | Division of Southeast Imports (DSEI) |
| 6/20/2008 | 29BGT06SOFT DRINK, IMITATION FRUIT FLAVORED, CARBONATED | Division of Southeast Imports (DSEI) | |
| 6/20/2008 | 29BGT06SOFT DRINK, IMITATION FRUIT FLAVORED, CARBONATED | Division of Southeast Imports (DSEI) | |
| 6/20/2008 | 29BGT06SOFT DRINK, IMITATION FRUIT FLAVORED, CARBONATED | Division of Southeast Imports (DSEI) | |
| 6/10/2008 | 29BCT02SOFT DRINK, CITRUS FRUIT FLAVORED, CARBONATED | 473LABELING | Florida District Office (FLA-DO) |
| 4/10/2008 | 29BCT07SOFT DRINK, SUBTROPICAL OR TROPICAL FRUIT FLAVORED, CARBONATED | 11UNSAFE COL | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Embotelladora Nacional S.A.'s FDA import refusal history?
Embotelladora Nacional S.A. (FEI: 3010120277) has 13 FDA import refusal record(s) in our database, spanning from 4/10/2008 to 2/9/2024.
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. Embotelladora Nacional S.A.'s FEI number is 3010120277.
What types of violations has Embotelladora Nacional S.A. received?
Embotelladora Nacional S.A. 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 Embotelladora Nacional S.A. come from?
All FDA import refusal data for Embotelladora Nacional S.A. 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.