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JB CHEMICAL AND PHARMA LTD

⚠️ Moderate Risk

FEI: 3015444566 • Mumbai • INDIA

FEI

FEI Number

3015444566

📍

Location

Mumbai

🇮🇳

Country

INDIA
🏢

Address

Cnergy I T Park, Unit A, , Mumbai, , India

Moderate Risk

FDA Import Risk Assessment

40.5
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/5/2021
Latest Refusal
10/5/2021
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
0.6×20%
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
10/5/2021
62LCY40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is JB CHEMICAL AND PHARMA LTD's FDA import refusal history?

JB CHEMICAL AND PHARMA LTD (FEI: 3015444566) has 1 FDA import refusal record(s) in our database, spanning from 10/5/2021 to 10/5/2021.

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. JB CHEMICAL AND PHARMA LTD's FEI number is 3015444566.

What types of violations has JB CHEMICAL AND PHARMA LTD received?

JB CHEMICAL AND PHARMA 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 JB CHEMICAL AND PHARMA LTD come from?

All FDA import refusal data for JB CHEMICAL AND PHARMA 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.