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Keshava Organics Pvt., Ltd.

⚠️ Moderate Risk

FEI: 3005421820 • Mumbai, Maharashtra • INDIA

FEI

FEI Number

3005421820

📍

Location

Mumbai, Maharashtra

🇮🇳

Country

INDIA
🏢

Address

Durian Estate, 321 Goregaon Mulund Link Road, Mumbai, Maharashtra, India

Moderate Risk

FDA Import Risk Assessment

37.1
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
8/21/2013
Latest Refusal
11/2/2011
Earliest Refusal

Score Breakdown

Violation Severity
76.7×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
11.1×10%
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

162×

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
8/21/2013
60SCS99ANTACID, N.E.C.
16DIRECTIONS
Division of Northeast Imports (DNEI)
11/2/2011
61XBS08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC)
16DIRECTIONS
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Keshava Organics Pvt., Ltd.'s FDA import refusal history?

Keshava Organics Pvt., Ltd. (FEI: 3005421820) has 2 FDA import refusal record(s) in our database, spanning from 11/2/2011 to 8/21/2013.

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. Keshava Organics Pvt., Ltd.'s FEI number is 3005421820.

What types of violations has Keshava Organics Pvt., Ltd. received?

Keshava Organics Pvt., 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 Keshava Organics Pvt., Ltd. come from?

All FDA import refusal data for Keshava Organics 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.