R Ranjan Dutta

⚠️ Moderate Risk

FEI: 3004543773 • Kolkata, West Bengal • INDIA

FEI

FEI Number

3004543773

📍

Location

Kolkata, West Bengal

🇮🇳

Country

INDIA

🏢

Address

34 Aheli Apts, Feeder Road, Kolkata, West Bengal, India

Moderate Risk

FDA Import Risk Assessment

43.4

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

6/28/2004

Latest Refusal

6/28/2004

Earliest Refusal

Score Breakdown

Violation Severity

70.0×40%

Refusal Volume

31.3×30%

Recency

0.0×20%

Frequency

60.0×10%

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

Violation Summary

1186×

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).

756×

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

Date	Product	Violations	Division
6/28/2004	66VAH99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
6/28/2004	62EBB99ANTI-HYPOTENSIVE N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
6/28/2004	64LDB07BETAMETHASONE SODIUM PHOSPHATE (GLUCOCORTICOID)	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
6/28/2004	62ODA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II)	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
6/28/2004	62OCB14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II)	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
6/28/2004	61NCB78SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT)	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)

Frequently Asked Questions

What is R Ranjan Dutta's FDA import refusal history?

R Ranjan Dutta (FEI: 3004543773) has 6 FDA import refusal record(s) in our database, spanning from 6/28/2004 to 6/28/2004.

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. R Ranjan Dutta's FEI number is 3004543773.

What types of violations has R Ranjan Dutta received?

R Ranjan Dutta 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 R Ranjan Dutta come from?

All FDA import refusal data for R Ranjan Dutta 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.