ImportRefusal LogoImportRefusal

Kosmos Health Care (p) Ltd.

⚠️ Moderate Risk

FEI: 3008580550 • Kolkata • INDIA

FEI

FEI Number

3008580550

📍

Location

Kolkata

🇮🇳

Country

INDIA
🏢

Address

4, Cossipore Road, , Kolkata, , India

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
12/3/2010
Latest Refusal
12/3/2010
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

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.

751×

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
12/3/2010
61HBJ99ANTI-BACTERIAL, N.E.C.
16DIRECTIONS
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Kosmos Health Care (p) Ltd.'s FDA import refusal history?

Kosmos Health Care (p) Ltd. (FEI: 3008580550) has 1 FDA import refusal record(s) in our database, spanning from 12/3/2010 to 12/3/2010.

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. Kosmos Health Care (p) Ltd.'s FEI number is 3008580550.

What types of violations has Kosmos Health Care (p) Ltd. received?

Kosmos Health Care (p) Ltd. 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 Kosmos Health Care (p) Ltd. come from?

All FDA import refusal data for Kosmos Health Care (p) 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.