ImportRefusal LogoImportRefusal

Fajate

✅ Low Risk

FEI: 3008983625 • Medellin • COLOMBIA

FEI

FEI Number

3008983625

📍

Location

Medellin

🇨🇴

Country

COLOMBIA
🏢

Address

Calle 9a, , Medellin, , Colombia

Low Risk

FDA Import Risk Assessment

18.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
2
Unique Violations
7/28/2011
Latest Refusal
7/28/2011
Earliest Refusal

Score Breakdown

Violation Severity
35.0×40%
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

3361×

INCONSPICU

Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

Refusal History

DateProductViolationsDivision
7/28/2011
66VDK99MISCELLANEOUS PATENT MEDICINES, ETC.
336INCONSPICU
472NO ENGLISH
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Fajate's FDA import refusal history?

Fajate (FEI: 3008983625) has 1 FDA import refusal record(s) in our database, spanning from 7/28/2011 to 7/28/2011.

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. Fajate's FEI number is 3008983625.

What types of violations has Fajate received?

Fajate 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 Fajate come from?

All FDA import refusal data for Fajate 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.