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Garmol

⚠️ Moderate Risk

FEI: 3004132260 • San Salvador • EL SALVADOR

FEI

FEI Number

3004132260

📍

Location

San Salvador

🇸🇻
🏢

Address

Calle Poniente #5 Y 23 Ave. 18, , San Salvador, , El Salvador

Moderate Risk

FDA Import Risk Assessment

38.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
2
Unique Violations
1/31/2005
Latest Refusal
1/31/2005
Earliest Refusal

Score Breakdown

Violation Severity
67.5×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

833×

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.

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)).

Refusal History

DateProductViolationsDivision
1/31/2005
37JCT99SAUCES, N.E.C.
324NO ENGLISH
Atlanta District Office (ATL-DO)
1/31/2005
37BEE21TAMALE (MULTIPLE FOOD SPECIALITIES, SIDE DISHES AND DESSERTS)
83NO PROCESS
Atlanta District Office (ATL-DO)
1/31/2005
17FEY99RED MEAT/EXOTIC RED MEAT SOUPS, STEWS, CHILI, RAVIOLI, N.E.C.
83NO PROCESS
Atlanta District Office (ATL-DO)
1/31/2005
23KEY99EDIBLE SEEDS, N.E.C.
83NO PROCESS
Atlanta District Office (ATL-DO)

Frequently Asked Questions

What is Garmol's FDA import refusal history?

Garmol (FEI: 3004132260) has 4 FDA import refusal record(s) in our database, spanning from 1/31/2005 to 1/31/2005.

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. Garmol's FEI number is 3004132260.

What types of violations has Garmol received?

Garmol has been cited for 2 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 Garmol come from?

All FDA import refusal data for Garmol 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.