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Eskay Fine Chemicals, Prop. S.Kant Pharma Pvt. Ltd.

⚠️ Moderate Risk

FEI: 3003999990 • Navi Mumbai, Maharashtra • INDIA

FEI

FEI Number

3003999990

📍

Location

Navi Mumbai, Maharashtra

🇮🇳

Country

INDIA
🏢

Address

Plot No. 7, Thane-Belapur Road, 3a Shivasagar Estate, Worli, Navi Mumbai, Maharashtra, India

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

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

Score Breakdown

Violation Severity
70.0×40%
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.

Refusal History

DateProductViolationsDivision
1/5/2007
61ACS99ANTI-AMEBIC, N.E.C.
16DIRECTIONS
New York District Office (NYK-DO)

Frequently Asked Questions

What is Eskay Fine Chemicals, Prop. S.Kant Pharma Pvt. Ltd.'s FDA import refusal history?

Eskay Fine Chemicals, Prop. S.Kant Pharma Pvt. Ltd. (FEI: 3003999990) has 1 FDA import refusal record(s) in our database, spanning from 1/5/2007 to 1/5/2007.

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. Eskay Fine Chemicals, Prop. S.Kant Pharma Pvt. Ltd.'s FEI number is 3003999990.

What types of violations has Eskay Fine Chemicals, Prop. S.Kant Pharma Pvt. Ltd. received?

Eskay Fine Chemicals, Prop. S.Kant Pharma Pvt. Ltd. has been cited for 1 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 Eskay Fine Chemicals, Prop. S.Kant Pharma Pvt. Ltd. come from?

All FDA import refusal data for Eskay Fine Chemicals, Prop. S.Kant Pharma Pvt. 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.