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Corfinse

⚠️ Moderate Risk

FEI: 3003746635 • Guayaquil, Guayas • ECUADOR

FEI

FEI Number

3003746635

📍

Location

Guayaquil, Guayas

🇪🇨

Country

ECUADOR
🏢

Address

Esmeraldas No. 200 Y Manuel Garcia, , Guayaquil, Guayas, Ecuador

Moderate Risk

FDA Import Risk Assessment

32.6
LowModerateHighCritical

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

Statistics

5
Total Refusals
9
Unique Violations
5/1/2003
Latest Refusal
8/15/2002
Earliest Refusal

Score Breakdown

Violation Severity
47.5×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

2183×

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.

3202×

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.

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.

3241×

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)).

3281×

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.

4821×

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.

621×

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).

831×

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.

3081×

MFR INSAN

The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.

Refusal History

DateProductViolationsDivision
5/1/2003
37BGT21TAMALE (MULTIPLE FOOD SPECIALITIES, SIDE DISHES AND DESSERTS)
218LIST INGRE
320LACKS FIRM
328USUAL NAME
482NUTRIT LBL
Los Angeles District Office (LOS-DO)
4/28/2003
16AEE45TUNA (ALBACORE, YELLOWFIN, BLUEFIN, SKIPJACK, ETC.)
321LACKS N/C
324NO ENGLISH
62NEEDS FCE
83NO PROCESS
Los Angeles District Office (LOS-DO)
4/28/2003
16JVN01CRAB
218LIST INGRE
Los Angeles District Office (LOS-DO)
9/10/2002
17YGT99MEAT AND MEAT PRODUCTS N.E.C., MEAT/EXOTIC MEAT PRODUCTS, N.E.C.
218LIST INGRE
320LACKS FIRM
Los Angeles District Office (LOS-DO)
8/15/2002
16EVT02CLAMS
308MFR INSAN
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Corfinse's FDA import refusal history?

Corfinse (FEI: 3003746635) has 5 FDA import refusal record(s) in our database, spanning from 8/15/2002 to 5/1/2003.

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. Corfinse's FEI number is 3003746635.

What types of violations has Corfinse received?

Corfinse has been cited for 9 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 Corfinse come from?

All FDA import refusal data for Corfinse 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.