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EXPORT E IMPORTS SAN RAFAEL

⚠️ Moderate Risk

FEI: 3010035638 • Huehuetenango • GUATEMALA

FEI

FEI Number

3010035638

📍

Location

Huehuetenango

🇬🇹

Country

GUATEMALA
🏢

Address

San Rafael Independencia, , Huehuetenango, , Guatemala

Moderate Risk

FDA Import Risk Assessment

46.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

28
Total Refusals
17
Unique Violations
5/3/2022
Latest Refusal
8/14/2007
Earliest Refusal

Score Breakdown

Violation Severity
57.4×40%
Refusal Volume
54.2×30%
Recency
26.1×20%
Frequency
19.0×10%
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

2186×

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.

2496×

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.

33006×

ALLERGEN

the label fails to declare all major food allergens present in the product, as required by section 403(w)(1).

3283×

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.

3203×

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.

2563×

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)).

112×

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).

2582×

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.

3242×

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)).

4822×

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.

2971×

AFLATOXIN

The article appears to contain a mycotoxin, a poisonous and deleterious substance which may render it injurious to health.

32801×

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.

1181×

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).

38651×

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.

4711×

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.

3211×

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.

4751×

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

DateProductViolationsDivision
5/3/2022
03EGT12WHITE BREAD, ROLLS, BUNS, ETC DOUGH
3300ALLERGEN
3865COLORLABEL
Division of Southeast Imports (DSEI)
5/3/2022
03EGT12WHITE BREAD, ROLLS, BUNS, ETC DOUGH
218LIST INGRE
3300ALLERGEN
Division of Southeast Imports (DSEI)
5/3/2022
03EGT12WHITE BREAD, ROLLS, BUNS, ETC DOUGH
218LIST INGRE
3300ALLERGEN
Division of Southeast Imports (DSEI)
5/3/2022
03EGT12WHITE BREAD, ROLLS, BUNS, ETC DOUGH
218LIST INGRE
3300ALLERGEN
Division of Southeast Imports (DSEI)
5/3/2022
03EGT12WHITE BREAD, ROLLS, BUNS, ETC DOUGH
218LIST INGRE
3300ALLERGEN
Division of Southeast Imports (DSEI)
5/3/2022
03EGT12WHITE BREAD, ROLLS, BUNS, ETC DOUGH
218LIST INGRE
3300ALLERGEN
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)
471CSTIC LBLG
475COSMETLBLG
Florida District Office (FLA-DO)
2/8/2010
07ADT02CORN CHIPS, BAKED
11UNSAFE COL
324NO ENGLISH
482NUTRIT LBL
Florida District Office (FLA-DO)
4/8/2008
23BGN07PEANUT, SHELLED
297AFLATOXIN
Florida District Office (FLA-DO)
3/10/2008
07BGT05POPCORN, POPPED, FRIED
11UNSAFE COL
218LIST INGRE
Florida District Office (FLA-DO)
2/20/2008
02AGY01CORN, WHOLE GRAIN
249FILTHY
321LACKS N/C
328USUAL NAME
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)
320LACKS FIRM
328USUAL NAME
Florida District Office (FLA-DO)
8/14/2007
23AGN07PEANUT, IN SHELL
320LACKS FIRM
328USUAL NAME
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.