Kerala Ayurveda Pharmacy Ltd
⚠️ High Risk
FEI: 3004341113 • Athani, Kerala • INDIA
FEI Number
3004341113
Location
Athani, Kerala
Country
INDIAAddress
Athani, Alwaye, Athani, Kerala, 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
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/2/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 6/2/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 8/11/2011 | 62GAL99ANTI-INFLAMMATORY N.E.C. | Seattle District Office (SEA-DO) | |
| 8/11/2011 | 62GAL99ANTI-INFLAMMATORY N.E.C. | Seattle District Office (SEA-DO) | |
| 8/11/2011 | 62GAL99ANTI-INFLAMMATORY N.E.C. | Seattle District Office (SEA-DO) | |
| 8/11/2011 | 62QBL99ANTI-RHEUMATIC N.E.C. | Seattle District Office (SEA-DO) | |
| 8/11/2011 | 62QBL99ANTI-RHEUMATIC N.E.C. | Seattle District Office (SEA-DO) | |
| 8/11/2011 | 62QBL99ANTI-RHEUMATIC N.E.C. | Seattle District Office (SEA-DO) | |
| 8/11/2011 | 62QBL99ANTI-RHEUMATIC N.E.C. | Seattle District Office (SEA-DO) | |
| 8/8/2006 | 63FBB99CARDIOTONIC N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 6/18/2004 | 60SAR99ANTACID, N.E.C. | New York District Office (NYK-DO) | |
| 6/18/2004 | 60SAL99ANTACID, N.E.C. | New York District Office (NYK-DO) | |
| 6/18/2004 | 60SAL99ANTACID, N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Kerala Ayurveda Pharmacy Ltd's FDA import refusal history?
Kerala Ayurveda Pharmacy Ltd (FEI: 3004341113) has 13 FDA import refusal record(s) in our database, spanning from 6/18/2004 to 6/2/2025.
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. Kerala Ayurveda Pharmacy Ltd's FEI number is 3004341113.
What types of violations has Kerala Ayurveda Pharmacy Ltd received?
Kerala Ayurveda Pharmacy Ltd 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 Kerala Ayurveda Pharmacy Ltd come from?
All FDA import refusal data for Kerala Ayurveda Pharmacy 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.