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Amazon Andes Export Sac

⚠️ Moderate Risk

FEI: 3011957908 • Limalima • PERU

FEI

FEI Number

3011957908

📍

Location

Limalima

🇵🇪

Country

PERU
🏢

Address

Piedra Del Sol 1720, , Limalima, , Peru

Moderate Risk

FDA Import Risk Assessment

26.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
4/12/2017
Latest Refusal
4/12/2017
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

2231×

FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
4/12/2017
54YBH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
223FALSE
3280FRNMFGREG
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Amazon Andes Export Sac's FDA import refusal history?

Amazon Andes Export Sac (FEI: 3011957908) has 1 FDA import refusal record(s) in our database, spanning from 4/12/2017 to 4/12/2017.

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. Amazon Andes Export Sac's FEI number is 3011957908.

What types of violations has Amazon Andes Export Sac received?

Amazon Andes Export Sac 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 Amazon Andes Export Sac come from?

All FDA import refusal data for Amazon Andes Export Sac 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.