Ketan B Patel
⚠️ Moderate Risk
FEI: 3005418438 • Ahmedabad, Gujarat • INDIA
FEI Number
3005418438
Location
Ahmedabad, Gujarat
Country
INDIAAddress
A/206 Surdas Marg, , Ahmedabad, Gujarat, 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).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/4/2009 | 54FYA99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 12/12/2005 | 66MCB60THIORIDAZINE (TRANQUILIZER) | New York District Office (NYK-DO) | |
| 12/12/2005 | 66MCB60THIORIDAZINE (TRANQUILIZER) | New York District Office (NYK-DO) | |
| 12/12/2005 | 66MCB60THIORIDAZINE (TRANQUILIZER) | New York District Office (NYK-DO) | |
| 12/12/2005 | 66MCB60THIORIDAZINE (TRANQUILIZER) | New York District Office (NYK-DO) | |
| 12/12/2005 | 66MCB60THIORIDAZINE (TRANQUILIZER) | New York District Office (NYK-DO) | |
| 12/12/2005 | 66MCB60THIORIDAZINE (TRANQUILIZER) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Ketan B Patel's FDA import refusal history?
Ketan B Patel (FEI: 3005418438) has 7 FDA import refusal record(s) in our database, spanning from 12/12/2005 to 8/4/2009.
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. Ketan B Patel's FEI number is 3005418438.
What types of violations has Ketan B Patel received?
Ketan B Patel 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 Ketan B Patel come from?
All FDA import refusal data for Ketan B Patel 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.