SA9 LANKA (PVT) LTD
⚠️ Moderate Risk
FEI: 3017696978 • Dehiwala, Colombo • SRI LANKA
FEI Number
3017696978
Location
Dehiwala, Colombo
Country
SRI LANKAAddress
33b, Vishnu Kovil Road, , Dehiwala, Colombo, Sri Lanka
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
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).
Refusal History
Frequently Asked Questions
What is SA9 LANKA (PVT) LTD's FDA import refusal history?
SA9 LANKA (PVT) LTD (FEI: 3017696978) has 3 FDA import refusal record(s) in our database, spanning from 4/12/2021 to 12/2/2021.
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. SA9 LANKA (PVT) LTD's FEI number is 3017696978.
What types of violations has SA9 LANKA (PVT) LTD received?
SA9 LANKA (PVT) LTD has been cited for 1 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 SA9 LANKA (PVT) LTD come from?
All FDA import refusal data for SA9 LANKA (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.