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Akums Drugs & Pharmaceuticals Ltd.

⚠️ High Risk

FEI: 3030582555 • Haridwar, Uttarakhand • INDIA

FEI

FEI Number

3030582555

📍

Location

Haridwar, Uttarakhand

🇮🇳

Country

INDIA
🏢

Address

Plot No. 26A, 27-30, Sector-8A, IIE, SIDCUL, Ranipur, Haridwar, Uttarakhand, India

High Risk

FDA Import Risk Assessment

62.5
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
12/1/2025
Latest Refusal
6/15/2016
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
97.5×20%
Frequency
3.2×10%
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

753×

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
12/1/2025
66VDB99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Southeast Imports (DSEI)
9/4/2020
66VCA99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Southeast Imports (DSEI)
6/15/2016
66VCY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is Akums Drugs & Pharmaceuticals Ltd.'s FDA import refusal history?

Akums Drugs & Pharmaceuticals Ltd. (FEI: 3030582555) has 3 FDA import refusal record(s) in our database, spanning from 6/15/2016 to 12/1/2025.

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. Akums Drugs & Pharmaceuticals Ltd.'s FEI number is 3030582555.

What types of violations has Akums Drugs & Pharmaceuticals Ltd. received?

Akums Drugs & Pharmaceuticals 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 Akums Drugs & Pharmaceuticals Ltd. come from?

All FDA import refusal data for Akums Drugs & Pharmaceuticals 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.