Hetero Labs Limited (Unit-11)
⚠️ High Risk
FEI: 3009471127 • Baddi, Himachal Pradesh • INDIA
FEI Number
3009471127
Location
Baddi, Himachal Pradesh
Country
INDIAAddress
Village Kalyanpur Chakkan Road, , Baddi, Himachal Pradesh, 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 |
|---|---|---|---|
| 12/1/2025 | 66VDB99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/3/2024 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/3/2024 | 62VDB77EMTRICITABINE; TENOFOVIR DISOPROXIL FUMERATE (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/19/2022 | 62VDY50EMTRICITABINE | Division of Southeast Imports (DSEI) | |
| 6/3/2021 | 64UCA99INHIBITOR N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/30/2020 | 61PCA99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/8/2020 | 66VCB99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/4/2020 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/27/2020 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/3/2020 | 62OCA09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/3/2020 | 61JDA16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/17/2020 | 66SCB51TADALAFIL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/15/2020 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/18/2019 | 62KAZ99ANTI-PERISTALTIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/30/2018 | 61JCY16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/27/2017 | 64UDB07MIGLITOL (INHIBITOR (DECARBOXYLASE)) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/9/2016 | 62CCA99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 6/17/2015 | 66SDB46CILOSTAZOL (VASODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/25/2014 | 62OCA09TELMISARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/11/2012 | 61JCB08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Hetero Labs Limited (Unit-11)'s FDA import refusal history?
Hetero Labs Limited (Unit-11) (FEI: 3009471127) has 20 FDA import refusal record(s) in our database, spanning from 6/11/2012 to 12/1/2025.
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 Limited (Unit-11)'s FEI number is 3009471127.
What types of violations has Hetero Labs Limited (Unit-11) received?
Hetero Labs Limited (Unit-11) 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 Limited (Unit-11) come from?
All FDA import refusal data for Hetero Labs Limited (Unit-11) 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.