Samarth Life
⚠️ High Risk
FEI: 3006289242 • Mumbai • 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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/17/2014 | 62CDK53SODIUM NITROPRUSSIDE (ANTI-HYPERTENSIVE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/17/2014 | 62CDK53SODIUM NITROPRUSSIDE (ANTI-HYPERTENSIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/23/2014 | 83GTOANTI-STREPTOKINASE | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 6/23/2014 | 83GTOANTI-STREPTOKINASE | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 6/23/2014 | 64RBK16VASOPRESSIN (INJ) (HORMONE) | 75UNAPPROVED | San Juan District Office (SJN-DO) |
| 6/23/2014 | 60QBK28THIOPENTAL SODIUM (ANESTHETIC) | 75UNAPPROVED | San Juan District Office (SJN-DO) |
| 6/23/2014 | 63NBA09PYRIDOSTIGMINE BROMIDE (CHOLINERGIC) | 75UNAPPROVED | San Juan District Office (SJN-DO) |
| 6/23/2014 | 63EAK13PROPRANOLOL HCL (CARDIAC DEPRESSANT) | 75UNAPPROVED | San Juan District Office (SJN-DO) |
| 6/23/2014 | 66SAK28NITROGLYCERIN (TAB) (VASODILATOR) | 75UNAPPROVED | San Juan District Office (SJN-DO) |
| 6/23/2014 | 54ADA18VITAMIN K (PHYTONADIONE) | 75UNAPPROVED | San Juan District Office (SJN-DO) |
| 5/16/2014 | 54ADA18VITAMIN K (PHYTONADIONE) | 473LABELING | San Juan District Office (SJN-DO) |
| 5/16/2014 | 64RBK16VASOPRESSIN (INJ) (HORMONE) | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 5/16/2014 | 60QBK28THIOPENTAL SODIUM (ANESTHETIC) | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 5/16/2014 | 63NBA09PYRIDOSTIGMINE BROMIDE (CHOLINERGIC) | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 5/16/2014 | 63EAK13PROPRANOLOL HCL (CARDIAC DEPRESSANT) | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 5/16/2014 | 66SAK28NITROGLYCERIN (TAB) (VASODILATOR) | 118NOT LISTED | San Juan District Office (SJN-DO) |
Frequently Asked Questions
What is Samarth Life's FDA import refusal history?
Samarth Life (FEI: 3006289242) has 16 FDA import refusal record(s) in our database, spanning from 5/16/2014 to 12/17/2014.
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. Samarth Life's FEI number is 3006289242.
What types of violations has Samarth Life received?
Samarth Life 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 Samarth Life come from?
All FDA import refusal data for Samarth Life 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.