Windlas Biotech Ltd
⚠️ High Risk
FEI: 3012172359 • Dehradun • INDIA
FEI Number
3012172359
Location
Dehradun
Country
INDIAAddress
Plant-2 Khasra No 141 To 143&145, , Dehradun, , 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 |
|---|---|---|---|
| 12/17/2025 | 60XCA02METOPROLOL (ANTI-ADRENERGIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/22/2025 | 62GDA90DICLOFENAC POTASSIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/12/2024 | 64ECY02PANCREATIN (ENZYME) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/12/2022 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/30/2021 | 62LCA47IVERMECTIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/29/2021 | 61MCA35DIVALPROEX SODIUM (ANTI-CONVULSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/1/2021 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/15/2017 | 61WCA46ITRACONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Windlas Biotech Ltd's FDA import refusal history?
Windlas Biotech Ltd (FEI: 3012172359) has 8 FDA import refusal record(s) in our database, spanning from 12/15/2017 to 12/17/2025.
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. Windlas Biotech Ltd's FEI number is 3012172359.
What types of violations has Windlas Biotech Ltd received?
Windlas Biotech Ltd 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 Windlas Biotech Ltd come from?
All FDA import refusal data for Windlas Biotech 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.