Vaidyaratnam Oushadhasala Pvt Ltd
⚠️ High Risk
FEI: 3010470271 • Thrissur, Kerala • INDIA
FEI Number
3010470271
Location
Thrissur, Kerala
Country
INDIAAddress
Ollur, Thakkattussery, , Thrissur, 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
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).
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/31/2025 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/31/2025 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/31/2025 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/13/2023 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/27/2019 | 62KDR99ANTI-PERISTALTIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/27/2019 | 61TDL99ANTI-EMETIC/NAUSEANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/27/2019 | 60LDL99ANALGESIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/27/2019 | 60LDL99ANALGESIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/13/2019 | 61SDJ99ANTI-ECZEMATIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/13/2019 | 61SDL99ANTI-ECZEMATIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/13/2019 | 66BDR99STIMULANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/13/2019 | 62TDR99ANTI-SECRETORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/11/2018 | 54FYJ99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 6/11/2018 | 54FYJ99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 6/11/2018 | 56GAJ99ANTIFUNGAL N.E.C. | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 6/11/2018 | 54FYJ99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 6/11/2018 | 54FYJ99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 6/11/2018 | 54FYJ99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 6/11/2018 | 54FYJ99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 6/11/2018 | 54FYJ99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 6/11/2018 | 54FYJ99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 12/10/2008 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | San Francisco District Office (SAN-DO) | |
| 12/10/2008 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | San Francisco District Office (SAN-DO) | |
| 12/10/2008 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | San Francisco District Office (SAN-DO) | |
| 11/24/2008 | 66VDL99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 11/24/2008 | 66VDL99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 11/24/2008 | 66VDL99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 11/24/2008 | 66VDL99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 11/24/2008 | 66VDL99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 11/24/2008 | 66VDL99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 11/24/2008 | 66VDL99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 11/24/2008 | 66VDL99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 11/24/2008 | 66VDL99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 11/24/2008 | 66VDL99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 11/24/2008 | 66VDL99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 11/24/2008 | 66VDL99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 11/24/2008 | 66VDL99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 11/24/2008 | 66VDL99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 11/24/2008 | 66VDL99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 11/24/2008 | 66VDL99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 11/24/2008 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 11/24/2008 | 66VDL99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 11/24/2008 | 66VDL99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 6/22/2007 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | New York District Office (NYK-DO) |
| 1/5/2005 | 62GAA99ANTI-INFLAMMATORY N.E.C. | 179AGR RX | New York District Office (NYK-DO) |
| 1/5/2005 | 62GAR99ANTI-INFLAMMATORY N.E.C. | 179AGR RX | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Vaidyaratnam Oushadhasala Pvt Ltd's FDA import refusal history?
Vaidyaratnam Oushadhasala Pvt Ltd (FEI: 3010470271) has 46 FDA import refusal record(s) in our database, spanning from 1/5/2005 to 7/31/2025.
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. Vaidyaratnam Oushadhasala Pvt Ltd's FEI number is 3010470271.
What types of violations has Vaidyaratnam Oushadhasala Pvt Ltd received?
Vaidyaratnam Oushadhasala Pvt Ltd has been cited for 4 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 Vaidyaratnam Oushadhasala Pvt Ltd come from?
All FDA import refusal data for Vaidyaratnam Oushadhasala 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.