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Kamud Drugs Pvt. Ltd.

⚠️ Moderate Risk

FEI: 3005333859 • Sangli, Maharashtra • INDIA

FEI

FEI Number

3005333859

📍

Location

Sangli, Maharashtra

🇮🇳

Country

INDIA
🏢

Address

N-6 & 8 MIDC, Kupwad, Taluka Miraj, Sangli, Maharashtra, India

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
1/28/2011
Latest Refusal
1/28/2011
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

1181×

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).

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
1/28/2011
65VIY27METHYPRYLON (SEDATIVE)
118NOT LISTED
16DIRECTIONS
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Kamud Drugs Pvt. Ltd.'s FDA import refusal history?

Kamud Drugs Pvt. Ltd. (FEI: 3005333859) has 1 FDA import refusal record(s) in our database, spanning from 1/28/2011 to 1/28/2011.

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. Kamud Drugs Pvt. Ltd.'s FEI number is 3005333859.

What types of violations has Kamud Drugs Pvt. Ltd. received?

Kamud Drugs 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 Kamud Drugs Pvt. Ltd. come from?

All FDA import refusal data for Kamud Drugs 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.