Exportaciones San Miguell
⚠️ Moderate Risk
FEI: 3006941681 • San Salvador, San Salvador • EL SALVADOR
FEI Number
3006941681
Location
San Salvador, San Salvador
Country
EL SALVADORAddress
Av. Las Camelias N2 Col. San Francisco, , San Salvador, 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.
LACKS N/C
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)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.
COUMARIN
The article appears to bear or contain Coumarin, a poisonous or deleterious substance, which may render it injurious to health.
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).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
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.
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.
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
N-RX INACT
The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/18/2009 | 62MBJ01CAMPHOR (ANTI-PRURITIC) | Florida District Office (FLA-DO) | |
| 12/18/2009 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/18/2009 | 28CHT51VANILLA, NATURAL EXTRACT OR FLAVOR (SPICE) | Division of Southeast Imports (DSEI) | |
| 3/18/2009 | 28MCT04VANILLA (VANILLIN) IMITATION FLAVOR | Division of Southeast Imports (DSEI) | |
| 3/18/2009 | 28MCT04VANILLA (VANILLIN) IMITATION FLAVOR | 2080COUMARIN | Division of Southeast Imports (DSEI) |
| 2/6/2009 | 37JCB99SAUCES, N.E.C. | Florida District Office (FLA-DO) | |
| 2/6/2009 | 23KGB99EDIBLE SEEDS, N.E.C. | Florida District Office (FLA-DO) | |
| 2/6/2009 | 28YGT99SPICES, FLAVORS AND SALT NOT MENTIONED ELSEWHERE, N.E.C. | Florida District Office (FLA-DO) | |
| 2/6/2009 | 02AGB02BARLEY, WHOLE GRAIN | Florida District Office (FLA-DO) | |
| 2/6/2009 | 29AGB02SOFT DRINK, CITRUS FRUIT FLAVORED, NONCARBONATED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Exportaciones San Miguell's FDA import refusal history?
Exportaciones San Miguell (FEI: 3006941681) has 10 FDA import refusal record(s) in our database, spanning from 2/6/2009 to 12/18/2009.
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. Exportaciones San Miguell's FEI number is 3006941681.
What types of violations has Exportaciones San Miguell received?
Exportaciones San Miguell has been cited for 10 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 Exportaciones San Miguell come from?
All FDA import refusal data for Exportaciones San Miguell 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.