Gloria De Lopez Fa Lazo A
⚠️ Moderate Risk
FEI: 3005357240 • San Salvador • EL SALVADOR
FEI Number
3005357240
Location
San Salvador
Country
EL SALVADORAddress
Colonia Utila Calle Al Puerto De La, , 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
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)).
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/20/2017 | 16AGH99FISH, N.E.C. | 473LABELING | Florida District Office (FLA-DO) |
| 3/20/2017 | 65RBA18SODIUM BICARBONATE (REPLENISHER) | 344WARNINGS | Florida District Office (FLA-DO) |
| 3/20/2017 | 37BGT21TAMALE (MULTIPLE FOOD SPECIALITIES, SIDE DISHES AND DESSERTS) | 324NO ENGLISH | Florida District Office (FLA-DO) |
| 3/20/2017 | 03AGT99BREAD/ROLLS/BUNS, N.E.C. | 324NO ENGLISH | Florida District Office (FLA-DO) |
| 3/20/2017 | 31AGT03COFFEE, INSTANT | 324NO ENGLISH | Florida District Office (FLA-DO) |
| 3/20/2017 | 05AGT01CORN FLAKES,PUFFS,KRISPIES,LOOPS READY TO EAT | 324NO ENGLISH | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Gloria De Lopez Fa Lazo A's FDA import refusal history?
Gloria De Lopez Fa Lazo A (FEI: 3005357240) has 6 FDA import refusal record(s) in our database, spanning from 3/20/2017 to 3/20/2017.
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. Gloria De Lopez Fa Lazo A's FEI number is 3005357240.
What types of violations has Gloria De Lopez Fa Lazo A received?
Gloria De Lopez Fa Lazo A has been cited for 3 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 Gloria De Lopez Fa Lazo A come from?
All FDA import refusal data for Gloria De Lopez Fa Lazo 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.