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Haco Industries Kenya Ltd.

⚠️ Moderate Risk

FEI: 3002676407 • Nairobi • KENYA

FEI

FEI Number

3002676407

📍

Location

Nairobi

🇰🇪

Country

KENYA
🏢

Address

Po Box 43903, , Nairobi, , Kenya

Moderate Risk

FDA Import Risk Assessment

40.1
LowModerateHighCritical

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

Statistics

9
Total Refusals
1
Unique Violations
2/21/2002
Latest Refusal
2/21/2002
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
37.0×30%
Recency
0.0×20%
Frequency
90.0×10%
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

1189×

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).

Refusal History

DateProductViolationsDivision
2/21/2002
63VAJ02HYDROQUINONE (DEPIGMENTOR)
118NOT LISTED
New York District Office (NYK-DO)
2/21/2002
63VAJ02HYDROQUINONE (DEPIGMENTOR)
118NOT LISTED
New York District Office (NYK-DO)
2/21/2002
63VAJ02HYDROQUINONE (DEPIGMENTOR)
118NOT LISTED
New York District Office (NYK-DO)
2/21/2002
63VAJ02HYDROQUINONE (DEPIGMENTOR)
118NOT LISTED
New York District Office (NYK-DO)
2/21/2002
63VAJ02HYDROQUINONE (DEPIGMENTOR)
118NOT LISTED
New York District Office (NYK-DO)
2/21/2002
63VAJ02HYDROQUINONE (DEPIGMENTOR)
118NOT LISTED
New York District Office (NYK-DO)
2/21/2002
63VAJ02HYDROQUINONE (DEPIGMENTOR)
118NOT LISTED
New York District Office (NYK-DO)
2/21/2002
63VAJ02HYDROQUINONE (DEPIGMENTOR)
118NOT LISTED
New York District Office (NYK-DO)
2/21/2002
63VAJ02HYDROQUINONE (DEPIGMENTOR)
118NOT LISTED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Haco Industries Kenya Ltd.'s FDA import refusal history?

Haco Industries Kenya Ltd. (FEI: 3002676407) has 9 FDA import refusal record(s) in our database, spanning from 2/21/2002 to 2/21/2002.

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. Haco Industries Kenya Ltd.'s FEI number is 3002676407.

What types of violations has Haco Industries Kenya Ltd. received?

Haco Industries Kenya Ltd. has been cited for 1 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 Haco Industries Kenya Ltd. come from?

All FDA import refusal data for Haco Industries Kenya Ltd. 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.