Alkem Laboratories Ltd
⚠️ High Risk
FEI: 3006370524 • Daman, Daman And Diu • INDIA
FEI Number
3006370524
Location
Daman, Daman And Diu
Country
INDIAAddress
167 Mahatma Gandhi Udyog Nagar Road, , Daman, Daman And Diu, 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).
DR QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/22/2025 | 61JCA08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | Division of Northeast Imports (DNEI) | |
| 10/24/2022 | 61MCK47LACOSAMIDE (ANTI-CONVULSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/5/2021 | 65VCA13CLOZAPINE (SEDATIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/17/2020 | 61PCA26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/17/2020 | 62OCA14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/27/2020 | 61TDH31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/26/2016 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/17/2016 | 64UCA06FINASTERIDE (INHIBITOR (DECARBOXYLASE)) | Cincinnati District Office (CIN-DO) | |
| 6/17/2016 | 64UCA06FINASTERIDE (INHIBITOR (DECARBOXYLASE)) | Cincinnati District Office (CIN-DO) | |
| 6/15/2015 | 62CCA99ANTI-HYPERTENSIVE N.E.C. | Baltimore District Office (BLT-DO) | |
| 6/15/2015 | 62CCA99ANTI-HYPERTENSIVE N.E.C. | Baltimore District Office (BLT-DO) | |
| 6/15/2015 | 62CCA99ANTI-HYPERTENSIVE N.E.C. | Baltimore District Office (BLT-DO) | |
| 6/15/2015 | 62CCA99ANTI-HYPERTENSIVE N.E.C. | Baltimore District Office (BLT-DO) | |
| 11/28/2011 | 62KAE10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Alkem Laboratories Ltd's FDA import refusal history?
Alkem Laboratories Ltd (FEI: 3006370524) has 14 FDA import refusal record(s) in our database, spanning from 11/28/2011 to 9/22/2025.
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 Laboratories Ltd's FEI number is 3006370524.
What types of violations has Alkem Laboratories Ltd received?
Alkem Laboratories Ltd has been cited for 4 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 Laboratories Ltd come from?
All FDA import refusal data for Alkem Laboratories 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.