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Unique Chemicals (A Division of J.B. Chemicals & Pharmaceuticals Ltd.)

⚠️ Moderate Risk

FEI: 3004196193 • Bharuch, Gujarat • INDIA

FEI

FEI Number

3004196193

📍

Location

Bharuch, Gujarat

🇮🇳

Country

INDIA
🏢

Address

Plot No. 5, Phase Iv, G.I.D.C. Industrial Area, Panoli, , Bharuch, Gujarat, India

Moderate Risk

FDA Import Risk Assessment

41.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
3/14/2024
Latest Refusal
3/14/2024
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
11.2×30%
Recency
63.4×20%
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

22801×

DIRSEXMPT

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.

Refusal History

DateProductViolationsDivision
3/14/2024
62GCS18DICLOFENAC SODIUM (ANTI-INFLAMMATORY)
2280DIRSEXMPT
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Unique Chemicals (A Division of J.B. Chemicals & Pharmaceuticals Ltd.)'s FDA import refusal history?

Unique Chemicals (A Division of J.B. Chemicals & Pharmaceuticals Ltd.) (FEI: 3004196193) has 1 FDA import refusal record(s) in our database, spanning from 3/14/2024 to 3/14/2024.

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. Unique Chemicals (A Division of J.B. Chemicals & Pharmaceuticals Ltd.)'s FEI number is 3004196193.

What types of violations has Unique Chemicals (A Division of J.B. Chemicals & Pharmaceuticals Ltd.) received?

Unique Chemicals (A Division of J.B. Chemicals & Pharmaceuticals 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 Unique Chemicals (A Division of J.B. Chemicals & Pharmaceuticals Ltd.) come from?

All FDA import refusal data for Unique Chemicals (A Division of J.B. Chemicals & Pharmaceuticals 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.