INDOCO REMEDIES LTD
⚠️ High Risk
FEI: 3012541527 • AURANGABAD • INDIA
FEI Number
3012541527
Location
AURANGABAD
Country
INDIAAddress
B-20 MIDC WALUJ, , AURANGABAD, , 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 |
|---|---|---|---|
| 9/18/2025 | 61VDY01SIMETHICONE (ANTI-FLATULENT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/22/2025 | 61KDA16DICYCLOMINE HCL (ANTI-CHOLINERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/7/2025 | 61KDY16DICYCLOMINE HCL (ANTI-CHOLINERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/20/2024 | 60QDY56BENZOCAINE (ANESTHETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/29/2021 | 60IDK12SODIUM CITRATE (ALKALIZER) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is INDOCO REMEDIES LTD's FDA import refusal history?
INDOCO REMEDIES LTD (FEI: 3012541527) has 5 FDA import refusal record(s) in our database, spanning from 10/29/2021 to 9/18/2025.
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. INDOCO REMEDIES LTD's FEI number is 3012541527.
What types of violations has INDOCO REMEDIES LTD received?
INDOCO REMEDIES 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 INDOCO REMEDIES LTD come from?
All FDA import refusal data for INDOCO REMEDIES 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.