Jai Radhe Sales
⚠️ Moderate Risk
FEI: 3005241236 • Ahmedabad, Gujarat • INDIA
FEI Number
3005241236
Location
Ahmedabad, Gujarat
Country
INDIAAddress
309/310 Harikrupa Tower, Old Sharda Mandir Road, 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).
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 |
|---|---|---|---|
| 6/22/2015 | 63BAY35CLENBUTEROL (BRONCHODILATOR) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 8/15/2013 | 62TOR06ESOMEPRAZOLE MAGNESIUM (ANTI-SECRETORY) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 8/19/2011 | 60WCA16MEBENDAZOLE (ANTHELMINTIC) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 3/22/2010 | 61WAS47KETOCONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 3/19/2010 | 63XAS12FLUORESCEIN SODIUM (DIAGNOSTIC AID) (DRUGS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 3/17/2010 | 62CAS41MINOXIDIL (ANTI-HYPERTENSIVE) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 2/25/2010 | 61KAS46SCOPOLAMINE HYDROBROMIDE (ANTI-CHOLINERGIC) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 7/20/2007 | 60LCY65SALSALATE (ANALGESIC) | 16DIRECTIONS | Southwest Import District Office (SWI-DO) |
| 9/8/2006 | 60QCR40LIDOCAINE HCL (ANESTHETIC) | Atlanta District Office (ATL-DO) |
Frequently Asked Questions
What is Jai Radhe Sales's FDA import refusal history?
Jai Radhe Sales (FEI: 3005241236) has 9 FDA import refusal record(s) in our database, spanning from 9/8/2006 to 6/22/2015.
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. Jai Radhe Sales's FEI number is 3005241236.
What types of violations has Jai Radhe Sales received?
Jai Radhe Sales has been cited for 3 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 Jai Radhe Sales come from?
All FDA import refusal data for Jai Radhe Sales 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.