Akums Drugs & Pharma
⚠️ High Risk
FEI: 3008489920 • Ranipur • INDIA
FEI Number
3008489920
Location
Ranipur
Country
INDIAAddress
19 20 21 Sector 6a Iie, , Ranipur, , India
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
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
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).
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/9/2025 | 54AFL15VITAMIN D2 (CALCIFEROL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/20/2025 | 61XDY08CHLORPHENIRAMINE MALEATE (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/3/2020 | 62HCA03TROVAFLOXACIN/AZITHROMYCIN (ANTI-MICROBIAL) | Division of Southeast Imports (DSEI) | |
| 8/14/2012 | 66VBA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Akums Drugs & Pharma's FDA import refusal history?
Akums Drugs & Pharma (FEI: 3008489920) has 4 FDA import refusal record(s) in our database, spanning from 8/14/2012 to 12/9/2025.
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 & Pharma's FEI number is 3008489920.
What types of violations has Akums Drugs & Pharma received?
Akums Drugs & Pharma has been cited for 3 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 & Pharma come from?
All FDA import refusal data for Akums Drugs & Pharma 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.