Jayco Chemical Industries
⚠️ Moderate Risk
FEI: 3003699053 • Thane, Maharashtra • INDIA
FEI Number
3003699053
Location
Thane, Maharashtra
Country
INDIAAddress
Kashimira, W.E. Higway, Thane, Maharashtra, 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
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.
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).
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
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 |
|---|---|---|---|
| 8/5/2014 | 66SCT08ISOXSUPRINE HCL (VASODILATOR) | 16DIRECTIONS | Cincinnati District Office (CIN-DO) |
| 11/15/2011 | 66SJY08ISOXSUPRINE HCL (VASODILATOR) | Atlanta District Office (ATL-DO) | |
| 3/17/2011 | 66SCR08ISOXSUPRINE HCL (VASODILATOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/14/2008 | 66SAS08ISOXSUPRINE HCL (VASODILATOR) | 72NEW VET DR | Florida District Office (FLA-DO) |
| 2/8/2008 | 66SDS08ISOXSUPRINE HCL (VASODILATOR) | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 12/10/2007 | 66SCS08ISOXSUPRINE HCL (VASODILATOR) | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is Jayco Chemical Industries's FDA import refusal history?
Jayco Chemical Industries (FEI: 3003699053) has 6 FDA import refusal record(s) in our database, spanning from 12/10/2007 to 8/5/2014.
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. Jayco Chemical Industries's FEI number is 3003699053.
What types of violations has Jayco Chemical Industries received?
Jayco Chemical Industries has been cited for 5 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 Jayco Chemical Industries come from?
All FDA import refusal data for Jayco Chemical Industries 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.