Om Medicals
⚠️ High Risk
FEI: 3008611745 • Adyar Chennai, Tamil Nadu • INDIA
FEI Number
3008611745
Location
Adyar Chennai, Tamil Nadu
Country
INDIAAddress
No 9 Lb Road, , Adyar Chennai, Tamil Nadu, 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 |
|---|---|---|---|
| 6/24/2015 | 61TDY31DOMPERIDONE | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/24/2015 | 61LDY38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/24/2015 | 60IDY01POTASSIUM CITRATE (ALKALIZER) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/24/2015 | 61PDY26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/24/2015 | 61JDY14SIMVASTATIN (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/24/2015 | 62ODY18BISOPROLOL FUMARATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/24/2015 | 62ODY14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 6/24/2015 | 62CDY68OLMESARTAN MEDOXOMIL | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Om Medicals's FDA import refusal history?
Om Medicals (FEI: 3008611745) has 8 FDA import refusal record(s) in our database, spanning from 6/24/2015 to 6/24/2015.
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. Om Medicals's FEI number is 3008611745.
What types of violations has Om Medicals received?
Om Medicals 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 Om Medicals come from?
All FDA import refusal data for Om Medicals 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.