Amrutanjan Limited
⚠️ High Risk
FEI: 3002729113 • Mylopore, TN • INDIA
FEI Number
3002729113
Location
Mylopore, TN
Country
INDIAAddress
4245 Luz Church Road, , Mylopore, TN, 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).
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/25/2024 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 11/25/2024 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/16/2006 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 473LABELING | Florida District Office (FLA-DO) |
| 6/2/2006 | 62FBJ99ANTI-INFECTIVE, TOPICAL N.E.C. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 2/1/2006 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Southwest Import District Office (SWI-DO) | |
| 2/1/2006 | 66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Southwest Import District Office (SWI-DO) | |
| 11/16/2005 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 11/16/2005 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 5/7/2002 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Amrutanjan Limited's FDA import refusal history?
Amrutanjan Limited (FEI: 3002729113) has 9 FDA import refusal record(s) in our database, spanning from 5/7/2002 to 11/25/2024.
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. Amrutanjan Limited's FEI number is 3002729113.
What types of violations has Amrutanjan Limited received?
Amrutanjan Limited 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 Amrutanjan Limited come from?
All FDA import refusal data for Amrutanjan Limited 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.