EXPORT E IMPORTS SAN RAFAEL
⚠️ Moderate Risk
FEI: 3010035638 • Huehuetenango • GUATEMALA
FEI Number
3010035638
Location
Huehuetenango
Country
GUATEMALAAddress
San Rafael Independencia, , Huehuetenango, , Guatemala
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
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.
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
ALLERGEN
the label fails to declare all major food allergens present in the product, as required by section 403(w)(1).
USUAL NAME
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)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be.
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.
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)).
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).
FLAVR LBLG
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain an artificial flavoring and it fails to bear labeling stating that fact.
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)).
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.
AFLATOXIN
The article appears to contain a mycotoxin, a poisonous and deleterious substance which may render it injurious to health.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
COLORLABEL
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.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
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.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/3/2022 | 03EGT12WHITE BREAD, ROLLS, BUNS, ETC DOUGH | Division of Southeast Imports (DSEI) | |
| 5/3/2022 | 03EGT12WHITE BREAD, ROLLS, BUNS, ETC DOUGH | Division of Southeast Imports (DSEI) | |
| 5/3/2022 | 03EGT12WHITE BREAD, ROLLS, BUNS, ETC DOUGH | Division of Southeast Imports (DSEI) | |
| 5/3/2022 | 03EGT12WHITE BREAD, ROLLS, BUNS, ETC DOUGH | Division of Southeast Imports (DSEI) | |
| 5/3/2022 | 03EGT12WHITE BREAD, ROLLS, BUNS, ETC DOUGH | Division of Southeast Imports (DSEI) | |
| 5/3/2022 | 03EGT12WHITE BREAD, ROLLS, BUNS, ETC DOUGH | Division of Southeast Imports (DSEI) | |
| 9/6/2019 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 9/6/2019 | 02AGT99GRAIN, WHOLE, N.E.C. | 258FLAVR LBLG | Division of Southeast Imports (DSEI) |
| 9/6/2019 | 02AGT99GRAIN, WHOLE, N.E.C. | 258FLAVR LBLG | Division of Southeast Imports (DSEI) |
| 9/6/2019 | 02AGT99GRAIN, WHOLE, N.E.C. | 256INCONSPICU | Division of Southeast Imports (DSEI) |
| 9/6/2019 | 05YGT99CEREAL PREPARATIONS NOT ELSEWHERE MENTIONED, N.E.C. | 256INCONSPICU | Division of Southeast Imports (DSEI) |
| 9/6/2019 | 05YGT99CEREAL PREPARATIONS NOT ELSEWHERE MENTIONED, N.E.C. | 256INCONSPICU | Division of Southeast Imports (DSEI) |
| 5/21/2019 | 03EGT12WHITE BREAD, ROLLS, BUNS, ETC DOUGH | 249FILTHY | Division of Southeast Imports (DSEI) |
| 5/21/2019 | 03EGT12WHITE BREAD, ROLLS, BUNS, ETC DOUGH | 249FILTHY | Division of Southeast Imports (DSEI) |
| 5/21/2019 | 03EGT12WHITE BREAD, ROLLS, BUNS, ETC DOUGH | 249FILTHY | Division of Southeast Imports (DSEI) |
| 12/20/2018 | 63RBY06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/27/2010 | 25FGY03CORN AND PEPPERS, DRIED OR PASTE | 249FILTHY | Florida District Office (FLA-DO) |
| 5/27/2010 | 25FGY03CORN AND PEPPERS, DRIED OR PASTE | 249FILTHY | Florida District Office (FLA-DO) |
| 2/8/2010 | 53TD05HAIR PREPARATIONS (NON-COLORING), COSMETIC PRODUCTS CONTAINING ANIMAL BY-PRODUCTS (PORCINE) | Florida District Office (FLA-DO) | |
| 2/8/2010 | 07ADT02CORN CHIPS, BAKED | Florida District Office (FLA-DO) | |
| 4/8/2008 | 23BGN07PEANUT, SHELLED | 297AFLATOXIN | Florida District Office (FLA-DO) |
| 3/10/2008 | 07BGT05POPCORN, POPPED, FRIED | Florida District Office (FLA-DO) | |
| 2/20/2008 | 02AGY01CORN, WHOLE GRAIN | Florida District Office (FLA-DO) | |
| 1/7/2008 | 03EGT12WHITE BREAD, ROLLS, BUNS, ETC DOUGH | 482NUTRIT LBL | Florida District Office (FLA-DO) |
| 1/7/2008 | 23KGY99EDIBLE SEEDS, N.E.C. | 324NO ENGLISH | Florida District Office (FLA-DO) |
| 8/14/2007 | 24AGN99BEANS, CORN, AND PEA, N.E.C. (VEGETABLE) | Florida District Office (FLA-DO) | |
| 8/14/2007 | 23AGN07PEANUT, IN SHELL | Florida District Office (FLA-DO) | |
| 8/14/2007 | 28AGH08CAPSICUMS (CAYENNE CHILI, HOT PEPPERS), WHOLE (SPICE) | 320LACKS FIRM | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is EXPORT E IMPORTS SAN RAFAEL's FDA import refusal history?
EXPORT E IMPORTS SAN RAFAEL (FEI: 3010035638) has 28 FDA import refusal record(s) in our database, spanning from 8/14/2007 to 5/3/2022.
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. EXPORT E IMPORTS SAN RAFAEL's FEI number is 3010035638.
What types of violations has EXPORT E IMPORTS SAN RAFAEL received?
EXPORT E IMPORTS SAN RAFAEL has been cited for 17 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 EXPORT E IMPORTS SAN RAFAEL come from?
All FDA import refusal data for EXPORT E IMPORTS SAN RAFAEL 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.