ImportRefusal LogoImportRefusal

Chemiefine

✅ Low Risk

FEI: 3003991889 • Mumbai • INDIA

FEI

FEI Number

3003991889

📍

Location

Mumbai

🇮🇳

Country

INDIA
🏢

Address

24, Mahakali Caves Road, , Mumbai, , India

Low Risk

FDA Import Risk Assessment

19.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
4/22/2004
Latest Refusal
4/22/2004
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

4722×

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
4/22/2004
80KMJLUBRICANT, PATIENT
472NO ENGLISH
Los Angeles District Office (LOS-DO)
4/22/2004
80KMJLUBRICANT, PATIENT
472NO ENGLISH
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Chemiefine's FDA import refusal history?

Chemiefine (FEI: 3003991889) has 2 FDA import refusal record(s) in our database, spanning from 4/22/2004 to 4/22/2004.

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. Chemiefine's FEI number is 3003991889.

What types of violations has Chemiefine received?

Chemiefine 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 Chemiefine come from?

All FDA import refusal data for Chemiefine 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.