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J. B. Chemicals and Pharmaceuticals Limited

⚠️ Moderate Risk

FEI: 3003053502 • Anklesvar, Gujarat • INDIA

FEI

FEI Number

3003053502

📍

Location

Anklesvar, Gujarat

🇮🇳

Country

INDIA
🏢

Address

215 - 219 Gidc Industrial Area, Panoli, Anklesvar, Gujarat, India

Moderate Risk

FDA Import Risk Assessment

41.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/19/2021
Latest Refusal
12/19/2021
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
4.7×20%
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

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
12/19/2021
60SCY28RANITIDINE (ANTACID)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is J. B. Chemicals and Pharmaceuticals Limited's FDA import refusal history?

J. B. Chemicals and Pharmaceuticals Limited (FEI: 3003053502) has 1 FDA import refusal record(s) in our database, spanning from 12/19/2021 to 12/19/2021.

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. J. B. Chemicals and Pharmaceuticals Limited's FEI number is 3003053502.

What types of violations has J. B. Chemicals and Pharmaceuticals Limited received?

J. B. Chemicals and Pharmaceuticals Limited 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 J. B. Chemicals and Pharmaceuticals Limited come from?

All FDA import refusal data for J. B. Chemicals and Pharmaceuticals Limited 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.