Sami Labs Limited
⚠️ Moderate Risk
FEI: 3003133150 • Bangalore • INDIA
FEI Number
3003133150
Location
Bangalore
Country
INDIAAddress
19/1 & 19/2, 1 Main, Ii Phase, Peenya Industrial Area, Bangalore, , India
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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
PESTICIDE2
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be adulterated because it contains a pesticide chemical, which is in violation of section 402(a)(2)(B). Contains:
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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/18/2014 | 54FBR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 3721PESTICIDE2 | Southwest Import District Office (SWI-DO) |
| 5/3/2013 | 54FBR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 3721PESTICIDE2 | Division of Northeast Imports (DNEI) |
| 5/3/2013 | 54FBR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 3721PESTICIDE2 | Division of Northeast Imports (DNEI) |
| 6/28/2005 | 61MCP99ANTI-CONVULSANT, N.E.C. | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Sami Labs Limited's FDA import refusal history?
Sami Labs Limited (FEI: 3003133150) has 4 FDA import refusal record(s) in our database, spanning from 6/28/2005 to 7/18/2014.
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. Sami Labs Limited's FEI number is 3003133150.
What types of violations has Sami Labs Limited received?
Sami Labs Limited has been cited for 5 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 Sami Labs Limited come from?
All FDA import refusal data for Sami Labs 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.