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Axon Drugs

⚠️ Moderate Risk

FEI: 3008236492 • Chenbaranbakkam • INDIA

FEI

FEI Number

3008236492

📍

Location

Chenbaranbakkam

🇮🇳

Country

INDIA
🏢

Address

148/12b Chennai, , Chenbaranbakkam, , India

Moderate Risk

FDA Import Risk Assessment

44.6
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
7/16/2025
Latest Refusal
12/23/2014
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
17.7×30%
Recency
75.4×20%
Frequency
1.9×10%
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

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

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
7/16/2025
62UDY11DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD)
472NO ENGLISH
Division of Southeast Imports (DSEI)
12/23/2014
62GCY41IBUPROFEN (ANTI-INFLAMMATORY)
75UNAPPROVED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Axon Drugs's FDA import refusal history?

Axon Drugs (FEI: 3008236492) has 2 FDA import refusal record(s) in our database, spanning from 12/23/2014 to 7/16/2025.

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. Axon Drugs's FEI number is 3008236492.

What types of violations has Axon Drugs received?

Axon Drugs 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 Axon Drugs come from?

All FDA import refusal data for Axon Drugs 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.