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Serum Institute Of India Ltd

⚠️ Moderate Risk

FEI: 3004913526 • Mumbai, Maharashtra • INDIA

FEI

FEI Number

3004913526

📍

Location

Mumbai, Maharashtra

🇮🇳

Country

INDIA
🏢

Address

501 Dalamal Tower, , Mumbai, Maharashtra, India

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
4/5/2007
Latest Refusal
4/5/2007
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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
4/5/2007
64MCB07FOLLISTIM (FOLLITROPIN BETA(RDNA)) (GONAD-STIMULATING PRINCIPLE)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Serum Institute Of India Ltd's FDA import refusal history?

Serum Institute Of India Ltd (FEI: 3004913526) has 1 FDA import refusal record(s) in our database, spanning from 4/5/2007 to 4/5/2007.

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. Serum Institute Of India Ltd's FEI number is 3004913526.

What types of violations has Serum Institute Of India Ltd received?

Serum Institute Of India 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 Serum Institute Of India Ltd come from?

All FDA import refusal data for Serum Institute Of India 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.