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EXMED PHARMACUETICALS

⚠️ High Risk

FEI: 3015937570 • Valsad • INDIA

FEI

FEI Number

3015937570

📍

Location

Valsad

🇮🇳

Country

INDIA
🏢

Address

Plot No 133 1 And 133 2, , Valsad, , India

High Risk

FDA Import Risk Assessment

56.4
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

2
Total Refusals
1
Unique Violations
6/20/2025
Latest Refusal
11/18/2019
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
73.9×20%
Frequency
3.6×10%
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

752×

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
6/20/2025
61XCA45CETIRIZINE HYDROCHLORIDE (ANTI-HISTAMINIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)
11/18/2019
66MCA83HYDROXYZINE HCL (TRANQUILIZER)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is EXMED PHARMACUETICALS's FDA import refusal history?

EXMED PHARMACUETICALS (FEI: 3015937570) has 2 FDA import refusal record(s) in our database, spanning from 11/18/2019 to 6/20/2025.

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. EXMED PHARMACUETICALS's FEI number is 3015937570.

What types of violations has EXMED PHARMACUETICALS received?

EXMED PHARMACUETICALS 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 EXMED PHARMACUETICALS come from?

All FDA import refusal data for EXMED PHARMACUETICALS 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.