HETERO HEALTHCARE LIMITED
⚠️ High Risk
FEI: 3013890701 • Kamrup, Assam • INDIA
FEI Number
3013890701
Location
Kamrup, Assam
Country
INDIAAddress
AIIDC Industrial Growth Center, Changsari, Niz Sindurighopa, Sila Sindurighopa, Kamrup, Assam, 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 |
|---|---|---|---|
| 7/11/2024 | 65VQY40THALIDOMIDE (SEDATIVE) | Division of Southeast Imports (DSEI) | |
| 9/10/2020 | 62VDA77EMTRICITABINE; TENOFOVIR DISOPROXIL FUMERATE (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/10/2020 | 62VDA77EMTRICITABINE; TENOFOVIR DISOPROXIL FUMERATE (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is HETERO HEALTHCARE LIMITED's FDA import refusal history?
HETERO HEALTHCARE LIMITED (FEI: 3013890701) has 3 FDA import refusal record(s) in our database, spanning from 9/10/2020 to 7/11/2024.
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 HEALTHCARE LIMITED's FEI number is 3013890701.
What types of violations has HETERO HEALTHCARE LIMITED received?
HETERO HEALTHCARE LIMITED 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 HETERO HEALTHCARE LIMITED come from?
All FDA import refusal data for HETERO HEALTHCARE LIMITED 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.