Hetero Labs Ltd. Unit VI
⚠️ High Risk
FEI: 3008294355 • Mahaboob Nagar, Telangana • INDIA
FEI Number
3008294355
Location
Mahaboob Nagar, Telangana
Country
INDIAAddress
Sy. No. Part Of 410, 411, Tsiic, Pharma Sez, Pollepally (V), Jadcherla (M), Mahaboob Nagar, Telangana, 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 |
|---|---|---|---|
| 10/27/2025 | 62ODA41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | Division of Southeast Imports (DSEI) | |
| 11/10/2021 | 62TDA07PANTOPRAZOLE SODIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/12/2021 | 62ICB85LETROZOLE (ANTI-NEOPLASTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/24/2019 | 62VDY78LAMIVUDINE; ZIDOVUDINE (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Hetero Labs Ltd. Unit VI's FDA import refusal history?
Hetero Labs Ltd. Unit VI (FEI: 3008294355) has 4 FDA import refusal record(s) in our database, spanning from 4/24/2019 to 10/27/2025.
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. Unit VI's FEI number is 3008294355.
What types of violations has Hetero Labs Ltd. Unit VI received?
Hetero Labs Ltd. Unit VI 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 Labs Ltd. Unit VI come from?
All FDA import refusal data for Hetero Labs Ltd. Unit VI 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.