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Dr. Kalyan Banerjee

⚠️ Moderate Risk

FEI: 3002887171 • India • INDIA

FEI

FEI Number

3002887171

📍

Location

India

🇮🇳

Country

INDIA
🏢

Address

1-1691 C.R. Park, , New Delhi, India, , India

Moderate Risk

FDA Import Risk Assessment

25.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
12/5/2007
Latest Refusal
12/5/2007
Earliest Refusal

Score Breakdown

Violation Severity
53.3×40%
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

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

3311×

DR QUALITC

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.

3331×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

Refusal History

DateProductViolationsDivision
12/5/2007
66VIP99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
331DR QUALITC
333LACKS FIRM
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Dr. Kalyan Banerjee's FDA import refusal history?

Dr. Kalyan Banerjee (FEI: 3002887171) has 1 FDA import refusal record(s) in our database, spanning from 12/5/2007 to 12/5/2007.

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. Dr. Kalyan Banerjee's FEI number is 3002887171.

What types of violations has Dr. Kalyan Banerjee received?

Dr. Kalyan Banerjee has been cited for 3 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 Dr. Kalyan Banerjee come from?

All FDA import refusal data for Dr. Kalyan Banerjee 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.