Jageswari Medicine Store
⚠️ Moderate Risk
FEI: 3008102775 • Bhubaneswar, Odisha • INDIA
FEI Number
3008102775
Location
Bhubaneswar, Odisha
Country
INDIAAddress
374, , Bhubaneswar, Odisha, 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
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).
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/13/2011 | 54ACK99VITAMIN, N.E.C. | 11UNSAFE COL | New Orleans District Office (NOL-DO) |
| 12/13/2011 | 60CDK48OXYMETAZOLINE HCL (ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/13/2011 | 56BDK03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Jageswari Medicine Store's FDA import refusal history?
Jageswari Medicine Store (FEI: 3008102775) has 3 FDA import refusal record(s) in our database, spanning from 12/13/2011 to 12/13/2011.
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. Jageswari Medicine Store's FEI number is 3008102775.
What types of violations has Jageswari Medicine Store received?
Jageswari Medicine Store has been cited for 2 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 Jageswari Medicine Store come from?
All FDA import refusal data for Jageswari Medicine Store 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.