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Cabex Sa Natural Prodcuts Exporter

⚠️ Moderate Risk

FEI: 3006107416 • Lima • PERU

FEI

FEI Number

3006107416

📍

Location

Lima

🇵🇪

Country

PERU
🏢

Address

Calle Surinam No 152 Sta Patricia La, , Lima, , Peru

Moderate Risk

FDA Import Risk Assessment

35.0
LowModerateHighCritical

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

Statistics

3
Total Refusals
3
Unique Violations
5/2/2008
Latest Refusal
5/2/2008
Earliest Refusal

Score Breakdown

Violation Severity
63.3×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

1183×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

4833×

DRUG NAME

The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.

753×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
5/2/2008
60NAL99ANDROGEN, N.E.C.
118NOT LISTED
483DRUG NAME
75UNAPPROVED
San Francisco District Office (SAN-DO)
5/2/2008
60NAR99ANDROGEN, N.E.C.
118NOT LISTED
483DRUG NAME
75UNAPPROVED
San Francisco District Office (SAN-DO)
5/2/2008
60NAE99ANDROGEN, N.E.C.
118NOT LISTED
483DRUG NAME
75UNAPPROVED
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Cabex Sa Natural Prodcuts Exporter's FDA import refusal history?

Cabex Sa Natural Prodcuts Exporter (FEI: 3006107416) has 3 FDA import refusal record(s) in our database, spanning from 5/2/2008 to 5/2/2008.

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. Cabex Sa Natural Prodcuts Exporter's FEI number is 3006107416.

What types of violations has Cabex Sa Natural Prodcuts Exporter received?

Cabex Sa Natural Prodcuts Exporter 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 Cabex Sa Natural Prodcuts Exporter come from?

All FDA import refusal data for Cabex Sa Natural Prodcuts Exporter 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.