Hetero Labs Ltd
⚠️ High Risk
FEI: 3007785633 • Sanath Nagar • INDIA
FEI Number
3007785633
Location
Sanath Nagar
Country
INDIAAddress
7-2-A2 Hetero Corporate, , Sanath Nagar, , 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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/21/2025 | 60CCA61MIRABEGRON (ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/22/2025 | 60CCA61MIRABEGRON (ADRENERGIC) | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 7/2/2025 | 61PAA26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/12/2022 | 62LDY29HYDROXYCHLOROQUINE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/12/2022 | 62LDY47IVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/10/2020 | 62VBS15TENOFOVIR DISOPROXIL FUMERATE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/6/2017 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/7/2017 | 62VCB17ABACAVIR SULFATE (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/8/2016 | 64TCY09IMATINIB MESYLATE (IMMUNOSUPPRESSIVE) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/20/2015 | 61JCB08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | Division of Southeast Imports (DSEI) | |
| 6/4/2012 | 62CIZ99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/22/2010 | 60TCS99ANTAGONIST, N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Hetero Labs Ltd's FDA import refusal history?
Hetero Labs Ltd (FEI: 3007785633) has 12 FDA import refusal record(s) in our database, spanning from 6/22/2010 to 11/21/2025.
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. Hetero Labs Ltd's FEI number is 3007785633.
What types of violations has Hetero Labs Ltd received?
Hetero Labs Ltd 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 Hetero Labs Ltd come from?
All FDA import refusal data for Hetero Labs 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.