NEPTUNE LIFE SCIENCES PVT LTD
⚠️ High Risk
FEI: 3019975182 • Thana Baddi • INDIA
FEI Number
3019975182
Location
Thana Baddi
Country
INDIAAddress
100-B Epip Phase Ii, , Thana Baddi, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/12/2025 | 61GCY81MUPIROCIN (ANTI-BACTERIAL, PART II) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/20/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 3/20/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is NEPTUNE LIFE SCIENCES PVT LTD's FDA import refusal history?
NEPTUNE LIFE SCIENCES PVT LTD (FEI: 3019975182) has 3 FDA import refusal record(s) in our database, spanning from 3/20/2025 to 11/12/2025.
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. NEPTUNE LIFE SCIENCES PVT LTD's FEI number is 3019975182.
What types of violations has NEPTUNE LIFE SCIENCES PVT LTD received?
NEPTUNE LIFE SCIENCES PVT LTD has been cited for 2 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 NEPTUNE LIFE SCIENCES PVT LTD come from?
All FDA import refusal data for NEPTUNE LIFE SCIENCES 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.