Amrutanjan Health Care Ltd
⚠️ High Risk
FEI: 3009626641 • Hyderabad, Telangana • INDIA
FEI Number
3009626641
Location
Hyderabad, Telangana
Country
INDIAAddress
Plot No 14, Industrial Developement, Hyderabad, Telangana, 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).
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.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/20/2024 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 2/7/2020 | 60LCY99ANALGESIC, N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 12/16/2016 | 60LBJ99ANALGESIC, N.E.C. | Division of Northeast Imports (DNEI) | |
| 3/28/2014 | 62GCJ99ANTI-INFLAMMATORY N.E.C. | New England District Office (NWE-DO) | |
| 3/28/2014 | 62GCJ99ANTI-INFLAMMATORY N.E.C. | New England District Office (NWE-DO) | |
| 3/28/2014 | 62GCJ99ANTI-INFLAMMATORY N.E.C. | New England District Office (NWE-DO) | |
| 9/21/2012 | 66VDR99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/21/2012 | 66VDR99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 6/26/2012 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Division of Northeast Imports (DNEI) |
| 6/26/2012 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Division of Northeast Imports (DNEI) |
| 12/9/2003 | 60LBJ99ANALGESIC, N.E.C. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Amrutanjan Health Care Ltd's FDA import refusal history?
Amrutanjan Health Care Ltd (FEI: 3009626641) has 11 FDA import refusal record(s) in our database, spanning from 12/9/2003 to 9/20/2024.
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 Health Care Ltd's FEI number is 3009626641.
What types of violations has Amrutanjan Health Care Ltd received?
Amrutanjan Health Care 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 Amrutanjan Health Care Ltd come from?
All FDA import refusal data for Amrutanjan Health Care 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.