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Bio-Nova Pharmaceuticals Pvt. Ltd.

⚠️ Moderate Risk

FEI: 3004809589 • New Delhi, IN-DL • INDIA

FEI

FEI Number

3004809589

📍

Location

New Delhi, IN-DL

🇮🇳

Country

INDIA
🏢

Address

C-66/1, Okhla Industrial Area, Phase II, New Delhi, IN-DL, 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
2/11/2005
Latest Refusal
2/11/2005
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

3441×

WARNINGS

It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.

Refusal History

DateProductViolationsDivision
2/11/2005
64NCA06FERROUS SULFATE (HEMATINIC)
344WARNINGS
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Bio-Nova Pharmaceuticals Pvt. Ltd.'s FDA import refusal history?

Bio-Nova Pharmaceuticals Pvt. Ltd. (FEI: 3004809589) has 1 FDA import refusal record(s) in our database, spanning from 2/11/2005 to 2/11/2005.

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. Bio-Nova Pharmaceuticals Pvt. Ltd.'s FEI number is 3004809589.

What types of violations has Bio-Nova Pharmaceuticals Pvt. Ltd. received?

Bio-Nova Pharmaceuticals Pvt. 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 Bio-Nova Pharmaceuticals Pvt. Ltd. come from?

All FDA import refusal data for Bio-Nova Pharmaceuticals Pvt. 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.