Gandules Inc. S.A.C.

⚠️ High Risk

FEI: 3011264942 • Jayanca, Lambayeque • PERU

FEI

FEI Number

3011264942

📍

Location

Jayanca, Lambayeque

🇵🇪

Country

PERU

🏢

Address

Predio Sono S/N Fnd. Fundo La Vina, , Jayanca, Lambayeque, Peru

High Risk

FDA Import Risk Assessment

62.2

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

Total Refusals

Unique Violations

11/30/2015

Latest Refusal

10/8/2015

Earliest Refusal

Score Breakdown

Violation Severity

87.7×40%

Refusal Volume

57.2×30%

Recency

0.0×20%

Frequency

100.0×10%

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

Violation Summary

18126×

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.

624×

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).

834×

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

Date	Product	Violations	Division
11/30/2015	24AEE17PIGEON PEAS	83NO PROCESS	San Juan District Office (SJN-DO)
11/30/2015	24AEE17PIGEON PEAS	83NO PROCESS	San Juan District Office (SJN-DO)
11/30/2015	24AEE17PIGEON PEAS	83NO PROCESS	San Juan District Office (SJN-DO)
11/2/2015	24AEE17PIGEON PEAS	181UNDER PRC	Baltimore District Office (BLT-DO)
11/2/2015	24AEE17PIGEON PEAS	83NO PROCESS	Baltimore District Office (BLT-DO)
10/22/2015	24AEE17PIGEON PEAS	181UNDER PRC	Division of Northeast Imports (DNEI)
10/22/2015	24AEE17PIGEON PEAS	181UNDER PRC	Division of Northeast Imports (DNEI)
10/22/2015	24AEE17PIGEON PEAS	181UNDER PRC	Division of Northeast Imports (DNEI)
10/22/2015	24AEE17PIGEON PEAS	181UNDER PRC	Division of Northeast Imports (DNEI)
10/22/2015	24AEE17PIGEON PEAS	181UNDER PRC	Division of Northeast Imports (DNEI)
10/22/2015	24AEE17PIGEON PEAS	181UNDER PRC	Division of Northeast Imports (DNEI)
10/22/2015	24AEE17PIGEON PEAS	181UNDER PRC	Division of Northeast Imports (DNEI)
10/21/2015	24AEE17PIGEON PEAS	181UNDER PRC	Division of Northeast Imports (DNEI)
10/21/2015	24AEE17PIGEON PEAS	181UNDER PRC	Division of Northeast Imports (DNEI)
10/21/2015	24AEE17PIGEON PEAS	181UNDER PRC	Division of Northeast Imports (DNEI)
10/21/2015	24AEE17PIGEON PEAS	181UNDER PRC	Division of Northeast Imports (DNEI)
10/21/2015	24AEE17PIGEON PEAS	181UNDER PRC	Division of Northeast Imports (DNEI)
10/21/2015	24AEE17PIGEON PEAS	181UNDER PRC	Division of Northeast Imports (DNEI)
10/21/2015	24AEE17PIGEON PEAS	181UNDER PRC	Division of Northeast Imports (DNEI)
10/21/2015	24AEE17PIGEON PEAS	181UNDER PRC	Division of Northeast Imports (DNEI)
10/21/2015	24AEE17PIGEON PEAS	181UNDER PRC	Division of Northeast Imports (DNEI)
10/14/2015	24AEE17PIGEON PEAS	62NEEDS FCE	San Juan District Office (SJN-DO)
10/14/2015	24AEE17PIGEON PEAS	62NEEDS FCE	San Juan District Office (SJN-DO)
10/14/2015	24AEE17PIGEON PEAS	62NEEDS FCE	San Juan District Office (SJN-DO)
10/14/2015	24AEE17PIGEON PEAS	62NEEDS FCE	San Juan District Office (SJN-DO)
10/8/2015	24AAE17PIGEON PEAS	181UNDER PRC	Division of Northeast Imports (DNEI)
10/8/2015	24AEE17PIGEON PEAS	181UNDER PRC	New York District Office (NYK-DO)
10/8/2015	24AEE17PIGEON PEAS	181UNDER PRC	New York District Office (NYK-DO)
10/8/2015	24AEE17PIGEON PEAS	181UNDER PRC	New York District Office (NYK-DO)
10/8/2015	24AEE17PIGEON PEAS	181UNDER PRC	New York District Office (NYK-DO)
10/8/2015	24AEE17PIGEON PEAS	181UNDER PRC	New York District Office (NYK-DO)
10/8/2015	24AEE17PIGEON PEAS	181UNDER PRC	New York District Office (NYK-DO)
10/8/2015	24AEE17PIGEON PEAS	181UNDER PRC	New York District Office (NYK-DO)
10/8/2015	24AEE17PIGEON PEAS	181UNDER PRC	New York District Office (NYK-DO)

Frequently Asked Questions

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

Gandules Inc. S.A.C. (FEI: 3011264942) has 34 FDA import refusal record(s) in our database, spanning from 10/8/2015 to 11/30/2015.

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 3011264942.

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

Gandules Inc. S.A.C. 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 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.