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Dr Parimal Banerjis Telemedicine Centre

⚠️ Moderate Risk

FEI: 3005190927 • Kolkata, West Bengal • INDIA

FEI

FEI Number

3005190927

📍

Location

Kolkata, West Bengal

🇮🇳

Country

INDIA
🏢

Address

5/1 D Deshapriya Park East Road, , Kolkata, West Bengal, India

Moderate Risk

FDA Import Risk Assessment

37.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
12/29/2005
Latest Refusal
12/29/2005
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

1183×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

753×

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
12/29/2005
61NBA99ANTI-DEPRESSANT N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
12/29/2005
61WBA99A-FUNGAL N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)
12/29/2005
62GBA99ANTI-INFLAMMATORY N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Dr Parimal Banerjis Telemedicine Centre's FDA import refusal history?

Dr Parimal Banerjis Telemedicine Centre (FEI: 3005190927) has 3 FDA import refusal record(s) in our database, spanning from 12/29/2005 to 12/29/2005.

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. Dr Parimal Banerjis Telemedicine Centre's FEI number is 3005190927.

What types of violations has Dr Parimal Banerjis Telemedicine Centre received?

Dr Parimal Banerjis Telemedicine Centre has been cited for 2 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 Parimal Banerjis Telemedicine Centre come from?

All FDA import refusal data for Dr Parimal Banerjis Telemedicine Centre 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.