Amrutanjan Health Care Limited
⚠️ High Risk
FEI: 3020342635 • Chengalpattu, Tamil Nadu • INDIA
FEI Number
3020342635
Location
Chengalpattu, Tamil Nadu
Country
INDIAAddress
Plot No.37,38, 39, Sidco Pharmaceutical Complex, Thiruporur Taluk, , Alathur, Chengalpattu, Tamil Nadu, 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).
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.
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).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/24/2025 | 60QDA07LIDOCAINE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/22/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/5/2025 | 62GBJ99ANTI-INFLAMMATORY N.E.C. | Division of Northeast Imports (DNEI) | |
| 12/5/2024 | 62UBJ99ANTI-TUSSIVE/COLD N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/27/2024 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 2/24/2023 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 2/24/2023 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 2/24/2023 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 2/24/2023 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 2/24/2023 | 53LD99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Amrutanjan Health Care Limited's FDA import refusal history?
Amrutanjan Health Care Limited (FEI: 3020342635) has 10 FDA import refusal record(s) in our database, spanning from 2/24/2023 to 7/24/2025.
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. Amrutanjan Health Care Limited's FEI number is 3020342635.
What types of violations has Amrutanjan Health Care Limited received?
Amrutanjan Health Care 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 Health Care Limited come from?
All FDA import refusal data for Amrutanjan Health Care 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.