ImportRefusal LogoImportRefusal

Bangalore Pharmaceutical and Research Laboratory Private Ltd.

⚠️ Moderate Risk

FEI: 3023352430 • Bengaluru, Karnataka • INDIA

FEI

FEI Number

3023352430

📍

Location

Bengaluru, Karnataka

🇮🇳

Country

INDIA
🏢

Address

Sy. No. 107/1A & 107/2, Mallapura Village, Kasaba Hobli, Tavarekere Road Off NH 4, Nelamangala Taluk, , Bengaluru, Karnataka, India

Moderate Risk

FDA Import Risk Assessment

45.9
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
2/13/2023
Latest Refusal
2/13/2023
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
27.8×20%
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
2/13/2023
66VCA99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Bangalore Pharmaceutical and Research Laboratory Private Ltd.'s FDA import refusal history?

Bangalore Pharmaceutical and Research Laboratory Private Ltd. (FEI: 3023352430) has 1 FDA import refusal record(s) in our database, spanning from 2/13/2023 to 2/13/2023.

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. Bangalore Pharmaceutical and Research Laboratory Private Ltd.'s FEI number is 3023352430.

What types of violations has Bangalore Pharmaceutical and Research Laboratory Private Ltd. received?

Bangalore Pharmaceutical and Research Laboratory Private 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 Bangalore Pharmaceutical and Research Laboratory Private Ltd. come from?

All FDA import refusal data for Bangalore Pharmaceutical and Research Laboratory Private 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.