ImportRefusal LogoImportRefusal

Ciron Drugs and Pharmaceuticals Pvt Ltd

⚠️ Moderate Risk

FEI: 3008223528 • Thane, Maharashtra • INDIA

FEI

FEI Number

3008223528

📍

Location

Thane, Maharashtra

🇮🇳

Country

INDIA
🏢

Address

35-37 43-45 CFC B Dewan Udyog, Village Aliyali, Palghar, Thane, 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
9/7/2017
Latest Refusal
9/7/2017
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
9/7/2017
62GCA18DICLOFENAC SODIUM (ANTI-INFLAMMATORY)
16DIRECTIONS
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Ciron Drugs and Pharmaceuticals Pvt Ltd's FDA import refusal history?

Ciron Drugs and Pharmaceuticals Pvt Ltd (FEI: 3008223528) has 1 FDA import refusal record(s) in our database, spanning from 9/7/2017 to 9/7/2017.

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. Ciron Drugs and Pharmaceuticals Pvt Ltd's FEI number is 3008223528.

What types of violations has Ciron Drugs and Pharmaceuticals Pvt Ltd received?

Ciron Drugs and Pharmaceuticals 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 Ciron Drugs and Pharmaceuticals Pvt Ltd come from?

All FDA import refusal data for Ciron Drugs and Pharmaceuticals 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.