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BHARAT SERUMS AND VACCINES LIMITED

⚠️ High Risk

FEI: 3017179607 • Ambernath • INDIA

FEI

FEI Number

3017179607

📍

Location

Ambernath

🇮🇳

Country

INDIA
🏢

Address

Plot No. K-27, Additional M.I.D.C, Ambernath, , India

High Risk

FDA Import Risk Assessment

51.9
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

1
Total Refusals
1
Unique Violations
12/7/2023
Latest Refusal
12/7/2023
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
57.6×20%
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
12/7/2023
62IDY86LEUPROLIDE ACETATE (ANTI-NEOPLASTIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is BHARAT SERUMS AND VACCINES LIMITED's FDA import refusal history?

BHARAT SERUMS AND VACCINES LIMITED (FEI: 3017179607) has 1 FDA import refusal record(s) in our database, spanning from 12/7/2023 to 12/7/2023.

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. BHARAT SERUMS AND VACCINES LIMITED's FEI number is 3017179607.

What types of violations has BHARAT SERUMS AND VACCINES LIMITED received?

BHARAT SERUMS AND VACCINES 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 BHARAT SERUMS AND VACCINES LIMITED come from?

All FDA import refusal data for BHARAT SERUMS AND VACCINES 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.