Harman Finochem Limited
⚠️ Moderate Risk
FEI: 3004101736 • Aurangabad, Maharashtra • INDIA
FEI Number
3004101736
Location
Aurangabad, Maharashtra
Country
INDIAAddress
A-100, A-100/1, A-100/2 & D-1, M.I.D.C Industrial Area, Shendra, Aurangabad, Maharashtra, 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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/11/2016 | 61PCS55METFORMIN HCL (ANTI-DIABETIC) | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
| 10/17/2014 | 61KIY22GLYCOPYRROLATE (ANTI-CHOLINERGIC) | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 8/26/2011 | 61MCR24PHENYTOIN SODIUM (ANTI-CONVULSANT) | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is Harman Finochem Limited's FDA import refusal history?
Harman Finochem Limited (FEI: 3004101736) has 3 FDA import refusal record(s) in our database, spanning from 8/26/2011 to 4/11/2016.
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. Harman Finochem Limited's FEI number is 3004101736.
What types of violations has Harman Finochem Limited received?
Harman Finochem Limited 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 Harman Finochem Limited come from?
All FDA import refusal data for Harman Finochem 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.