Diglmagen Sa De Cv
⚠️ Moderate Risk
FEI: 3004109459 • San Salvador • EL SALVADOR
FEI Number
3004109459
Location
San Salvador
Country
EL SALVADORAddress
Ave Las Garderilas, , San Salvador, , El Salvador
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
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.
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).
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)).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/8/2006 | 03AGT09NON-STANDARD BREAD/ROLLS/BUNS | 482NUTRIT LBL | Florida District Office (FLA-DO) |
| 12/8/2006 | 03AGT09NON-STANDARD BREAD/ROLLS/BUNS | 324NO ENGLISH | Florida District Office (FLA-DO) |
| 9/13/2006 | 03JGT10CREME FILLED/ICED COOKIE,BISCUIT,WAFER | 482NUTRIT LBL | Florida District Office (FLA-DO) |
| 8/1/2005 | 03HGT03OATMEAL PLAIN COOKIES,BISCUITS, AND WAFERS | Florida District Office (FLA-DO) | |
| 3/15/2005 | 03AGT09NON-STANDARD BREAD/ROLLS/BUNS | 11UNSAFE COL | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Diglmagen Sa De Cv's FDA import refusal history?
Diglmagen Sa De Cv (FEI: 3004109459) has 5 FDA import refusal record(s) in our database, spanning from 3/15/2005 to 12/8/2006.
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. Diglmagen Sa De Cv's FEI number is 3004109459.
What types of violations has Diglmagen Sa De Cv received?
Diglmagen Sa De Cv has been cited for 5 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 Diglmagen Sa De Cv come from?
All FDA import refusal data for Diglmagen 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.