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Gandules Inc. S.A.C.

⚠️ Moderate Risk

FEI: 3004264141 • Chiclayo, Lambayeque • PERU

FEI

FEI Number

3004264141

📍

Location

Chiclayo, Lambayeque

🇵🇪

Country

PERU
🏢

Address

Mz. A, Lote 4, Parque Industrial, Pimentel, Chiclayo, Lambayeque, Peru

Moderate Risk

FDA Import Risk Assessment

39.4
LowModerateHighCritical

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

Statistics

6
Total Refusals
6
Unique Violations
9/14/2015
Latest Refusal
1/29/2008
Earliest Refusal

Score Breakdown

Violation Severity
73.0×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
7.9×10%
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

37213×

PESTICIDE2

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be adulterated because it contains a pesticide chemical, which is in violation of section 402(a)(2)(B). Contains:

4823×

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.

1811×

UNDER PRC

The article appears to have inadequate processing in having been prepared, packed, or held under insanitary conditions whereby it may have been rendered injurious to health.

29201×

PESTICIDES

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be adulterated because it contains a pesticide chemical, which is in violation of section 402(a)(2)(B). Contains:

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.

Refusal History

DateProductViolationsDivision
9/14/2015
23KGT09QUINOA SEED (EDIBLE SEED)
3721PESTICIDE2
482NUTRIT LBL
New York District Office (NYK-DO)
5/11/2015
24AEE17PIGEON PEAS
181UNDER PRC
Florida District Office (FLA-DO)
12/24/2014
23KGT09QUINOA SEED (EDIBLE SEED)
3721PESTICIDE2
482NUTRIT LBL
New York District Office (NYK-DO)
8/22/2014
23KGT09QUINOA SEED (EDIBLE SEED)
3721PESTICIDE2
482NUTRIT LBL
New York District Office (NYK-DO)
11/12/2008
24FCP08PEPPER, HOT, N.E.C. (FRUIT USED AS VEGETABLE)
62NEEDS FCE
83NO PROCESS
Los Angeles District Office (LOS-DO)
1/29/2008
24FHT08PEPPER, HOT, N.E.C. (FRUIT USED AS VEGETABLE)
2920PESTICIDES
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Gandules Inc. S.A.C.'s FDA import refusal history?

Gandules Inc. S.A.C. (FEI: 3004264141) has 6 FDA import refusal record(s) in our database, spanning from 1/29/2008 to 9/14/2015.

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. Gandules Inc. S.A.C.'s FEI number is 3004264141.

What types of violations has Gandules Inc. S.A.C. received?

Gandules Inc. S.A.C. has been cited for 6 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 Gandules Inc. S.A.C. come from?

All FDA import refusal data for Gandules Inc. S.A.C. 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.