Agrol S.A.

⚠️ Moderate Risk

FEI: 3009547901 • Manta, Manabi • ECUADOR

FEI

FEI Number

3009547901

📍

Location

Manta, Manabi

🇪🇨

Country

ECUADOR

🏢

Address

Km. 2 1/2 Via San Mateo, Ciudadela Los Gavilanes, Manta, Manabi, Ecuador

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

Total Refusals

Unique Violations

5/1/2013

Latest Refusal

6/27/2006

Earliest Refusal

Score Breakdown

Violation Severity

90.0×40%

Refusal Volume

31.3×30%

Recency

0.0×20%

Frequency

8.8×10%

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

Violation Summary

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.

23603×

HISTAMINE

The article appears to bear or contain histamine, a poisonous and deleterious substance in such quantity as ordinarily renders it injurious to health.

3201×

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.

Refusal History

Date	Product	Violations	Division
5/1/2013	16AGC42SWORDFISH	249FILTHY 320LACKS FIRM	Florida District Office (FLA-DO)
6/13/2007	16AGT51MAHI MAHI	2360HISTAMINE 249FILTHY	Seattle District Office (SEA-DO)
6/13/2007	16AGT51MAHI MAHI	2360HISTAMINE 249FILTHY	Seattle District Office (SEA-DO)
6/13/2007	16AGT51MAHI MAHI	2360HISTAMINE 249FILTHY	Seattle District Office (SEA-DO)
6/13/2007	16AGT51MAHI MAHI	249FILTHY	Seattle District Office (SEA-DO)
6/27/2006	16AGT51MAHI MAHI	249FILTHY	Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Agrol S.A.'s FDA import refusal history?

Agrol S.A. (FEI: 3009547901) has 6 FDA import refusal record(s) in our database, spanning from 6/27/2006 to 5/1/2013.

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. Agrol S.A.'s FEI number is 3009547901.

What types of violations has Agrol S.A. received?

Agrol S.A. has been cited for 3 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 Agrol S.A. come from?

All FDA import refusal data for Agrol S.A. 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.