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Bigen Chemical Co.

✅ Low Risk

FEI: 3008014267 • Unknown, Unknown • PAKISTAN

FEI

FEI Number

3008014267

📍

Location

Unknown, Unknown

🇵🇰

Country

PAKISTAN
🏢

Address

Unkown, , Unknown, Unknown, Pakistan

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
10/19/2010
Latest Refusal
10/19/2010
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
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

4711×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

4751×

COSMETLBLG

It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.

Refusal History

DateProductViolationsDivision
10/19/2010
53FH99OTHER HAIR COLORING PREPARATIONS, N.E.C.
471CSTIC LBLG
475COSMETLBLG
New York District Office (NYK-DO)

Frequently Asked Questions

What is Bigen Chemical Co.'s FDA import refusal history?

Bigen Chemical Co. (FEI: 3008014267) has 1 FDA import refusal record(s) in our database, spanning from 10/19/2010 to 10/19/2010.

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. Bigen Chemical Co.'s FEI number is 3008014267.

What types of violations has Bigen Chemical Co. received?

Bigen Chemical Co. 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 Bigen Chemical Co. come from?

All FDA import refusal data for Bigen Chemical Co. 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.