Iayeshbhai Shah
⚠️ High Risk
FEI: 3010098963 • Rajkot, Gujarat • INDIA
FEI Number
3010098963
Location
Rajkot, Gujarat
Country
INDIAAddress
Porana Main Road, , Rajkot, Gujarat, 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 |
|---|---|---|---|
| 4/29/2013 | 64UCA99INHIBITOR N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 4/29/2013 | 62JDA13DONEPEZIL HCL (ANTI-PARKINSONIAN) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 4/29/2013 | 64UDA06FINASTERIDE (INHIBITOR (DECARBOXYLASE)) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 4/29/2013 | 60LCA05ASPIRIN (ANALGESIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 4/29/2013 | 60XCA17ATENOLOL (ANTI-ADRENERGIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 4/29/2013 | 62CLA99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 4/29/2013 | 61PCA31GLIMEPIRIDE (ANTI-DIABETIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 4/29/2013 | 61PCP62PIOGLITAZONE HCL | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Iayeshbhai Shah's FDA import refusal history?
Iayeshbhai Shah (FEI: 3010098963) has 8 FDA import refusal record(s) in our database, spanning from 4/29/2013 to 4/29/2013.
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. Iayeshbhai Shah's FEI number is 3010098963.
What types of violations has Iayeshbhai Shah received?
Iayeshbhai Shah 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 Iayeshbhai Shah come from?
All FDA import refusal data for Iayeshbhai Shah 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.