Sukmendu Ghosh

⚠️ Moderate Risk

FEI: 3004783174 • Sribhumi Kolkata • INDIA

FEI

FEI Number

3004783174

📍

Location

Sribhumi Kolkata

🇮🇳

Country

INDIA

🏢

Address

255 Canal Street, , Sribhumi Kolkata, , India

Moderate Risk

FDA Import Risk Assessment

41.6

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

11/15/2004

Latest Refusal

11/15/2004

Earliest Refusal

Score Breakdown

Violation Severity

70.0×40%

Refusal Volume

28.8×30%

Recency

0.0×20%

Frequency

50.0×10%

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

1185×

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).

755×

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
11/15/2004	61ECB06FEXOFENADINE HCL (ANTI-ASTHMATIC)	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
11/15/2004	63ECB13PROPRANOLOL HCL (CARDIAC DEPRESSANT)	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
11/15/2004	62CCB99ANTI-HYPERTENSIVE N.E.C.	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
11/15/2004	62OCB28ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II)	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)
11/15/2004	56BCF05AMPICILLIN (PENICILLIN, SYNTHETICALLY PRODUCED)	118NOT LISTED 75UNAPPROVED	New York District Office (NYK-DO)

Frequently Asked Questions

What is Sukmendu Ghosh's FDA import refusal history?

Sukmendu Ghosh (FEI: 3004783174) has 5 FDA import refusal record(s) in our database, spanning from 11/15/2004 to 11/15/2004.

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. Sukmendu Ghosh's FEI number is 3004783174.

What types of violations has Sukmendu Ghosh received?

Sukmendu Ghosh 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 Sukmendu Ghosh come from?

All FDA import refusal data for Sukmendu Ghosh 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.