Alkem Health Science
⚠️ High Risk
FEI: 3012147269 • Sikkim • INDIA
FEI Number
3012147269
Location
Sikkim
Country
INDIAAddress
Samardling Karek Block, , Sikkim, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/18/2025 | 60LDA01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/18/2025 | 56BDA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/20/2025 | 56CCL54CEFIXIME (CEPHALOSPORINS) | Division of Southeast Imports (DSEI) | |
| 10/24/2024 | 61TDE31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/5/2023 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/1/2021 | 62TCY07PANTOPRAZOLE SODIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/26/2019 | 61TDA31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/31/2018 | 56CCY54CEFIXIME (CEPHALOSPORINS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Alkem Health Science's FDA import refusal history?
Alkem Health Science (FEI: 3012147269) has 8 FDA import refusal record(s) in our database, spanning from 1/31/2018 to 12/18/2025.
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. Alkem Health Science's FEI number is 3012147269.
What types of violations has Alkem Health Science received?
Alkem Health Science 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 Alkem Health Science come from?
All FDA import refusal data for Alkem Health Science 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.