Khandelwal Laboratories Pvt. Ltd.
⚠️ High Risk
FEI: 3004128775 • Mumbai, Maharashtra • INDIA
FEI Number
3004128775
Location
Mumbai, Maharashtra
Country
INDIAAddress
79-87 D Lad Path, Next to Hakoba Mill Compound, Mumbai, Maharashtra, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/14/2025 | 61UAA05TAMOXIFEN CITRATE (ANTI-ESTROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/4/2018 | 62ICA85LETROZOLE (ANTI-NEOPLASTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/14/2005 | 61VAC99ANTI-FLATULENT N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Khandelwal Laboratories Pvt. Ltd.'s FDA import refusal history?
Khandelwal Laboratories Pvt. Ltd. (FEI: 3004128775) has 3 FDA import refusal record(s) in our database, spanning from 3/14/2005 to 10/14/2025.
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. Khandelwal Laboratories Pvt. Ltd.'s FEI number is 3004128775.
What types of violations has Khandelwal Laboratories Pvt. Ltd. received?
Khandelwal Laboratories Pvt. Ltd. has been cited for 1 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 Khandelwal Laboratories Pvt. Ltd. come from?
All FDA import refusal data for Khandelwal Laboratories Pvt. 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.