Jell Pharmaceuticals Pvt. Ltd.
⚠️ Moderate Risk
FEI: 3005205440 • Silvassa, Dadra and Nagar Haveli and Dam • INDIA
FEI Number
3005205440
Location
Silvassa, Dadra and Nagar Haveli and Dam
Country
INDIAAddress
No 142/2 Athal Industrial Estate, Village Athal, Silvassa, Dadra and Nagar Haveli and Dam, 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
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).
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 |
|---|---|---|---|
| 2/11/2013 | 62UBJ99ANTI-TUSSIVE/COLD N.E.C. | 118NOT LISTED | New York District Office (NYK-DO) |
| 6/20/2011 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 6/20/2011 | 66V99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 9/20/2010 | 53LH04FOOT POWDERS AND SPRAYS (SKIN CARE PREPARATIONS) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 1/6/2010 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 6/29/2009 | 65LBR99PROTECTANT N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Jell Pharmaceuticals Pvt. Ltd.'s FDA import refusal history?
Jell Pharmaceuticals Pvt. Ltd. (FEI: 3005205440) has 6 FDA import refusal record(s) in our database, spanning from 6/29/2009 to 2/11/2013.
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. Jell Pharmaceuticals Pvt. Ltd.'s FEI number is 3005205440.
What types of violations has Jell Pharmaceuticals Pvt. Ltd. received?
Jell Pharmaceuticals Pvt. Ltd. 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 Jell Pharmaceuticals Pvt. Ltd. come from?
All FDA import refusal data for Jell Pharmaceuticals Pvt. Ltd. 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.