SM PHARMA AND LABORATORIES LTD
⚠️ High Risk
FEI: 3018112871 • East Sikkim • INDIA
FEI Number
3018112871
Location
East Sikkim
Country
INDIAAddress
Plot No. 107-108 Namli, , East Sikkim, , 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 |
|---|---|---|---|
| 1/15/2026 | 61FCA63RIFAXIMIN (A-BACTERIAL PT. I) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/19/2025 | 66NCA06ARIPIPRAZOLE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | Division of Southeast Imports (DSEI) | |
| 12/10/2024 | 62GCA99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SM PHARMA AND LABORATORIES LTD's FDA import refusal history?
SM PHARMA AND LABORATORIES LTD (FEI: 3018112871) has 3 FDA import refusal record(s) in our database, spanning from 12/10/2024 to 1/15/2026.
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. SM PHARMA AND LABORATORIES LTD's FEI number is 3018112871.
What types of violations has SM PHARMA AND LABORATORIES LTD received?
SM PHARMA AND LABORATORIES 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 SM PHARMA AND LABORATORIES LTD come from?
All FDA import refusal data for SM PHARMA AND LABORATORIES 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.