Windlas Healthcare Private Limited
⚠️ Moderate Risk
FEI: 3005339091 • Dehradun, Uttaranchal • INDIA
FEI Number
3005339091
Location
Dehradun, Uttaranchal
Country
INDIAAddress
Plot No 183 & 192 Mohabewala Industrial, , Dehradun, Uttaranchal, India
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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 |
|---|---|---|---|
| 2/9/2023 | 61PDY26METFORMIN (ANTI-DIABETIC) | Division of Southeast Imports (DSEI) | |
| 3/18/2022 | 62OCY12VALSARTAN (ANTI-HYPERTENSIVE - PART II) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 6/25/2021 | 61EDA09MONTELUKAST SODIUM (ANTI-ASTHMATIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/5/2007 | 61GDK85OFLOXACIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 1/5/2007 | 60XCK02METOPROLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Windlas Healthcare Private Limited's FDA import refusal history?
Windlas Healthcare Private Limited (FEI: 3005339091) has 5 FDA import refusal record(s) in our database, spanning from 1/5/2007 to 2/9/2023.
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 Healthcare Private Limited's FEI number is 3005339091.
What types of violations has Windlas Healthcare Private Limited received?
Windlas Healthcare Private Limited 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 Windlas Healthcare Private Limited come from?
All FDA import refusal data for Windlas Healthcare Private 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.