ImportRefusal LogoImportRefusal

Sethsuva Ayurveda Hospital (Pvt) Ltd

⚠️ Moderate Risk

FEI: 3006657862 • Gampaha, Gampaha • SRI LANKA

FEI

FEI Number

3006657862

📍

Location

Gampaha, Gampaha

🇱🇰

Country

SRI LANKA
🏢

Address

No 258/40d Vihara Mawrhamakola South, , Gampaha, Gampaha, Sri Lanka

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
1
Unique Violations
2/12/2009
Latest Refusal
2/12/2009
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

751×

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

DateProductViolationsDivision
2/12/2009
54FCY99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Sethsuva Ayurveda Hospital (Pvt) Ltd's FDA import refusal history?

Sethsuva Ayurveda Hospital (Pvt) Ltd (FEI: 3006657862) has 1 FDA import refusal record(s) in our database, spanning from 2/12/2009 to 2/12/2009.

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. Sethsuva Ayurveda Hospital (Pvt) Ltd's FEI number is 3006657862.

What types of violations has Sethsuva Ayurveda Hospital (Pvt) Ltd received?

Sethsuva Ayurveda Hospital (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 Sethsuva Ayurveda Hospital (Pvt) Ltd come from?

All FDA import refusal data for Sethsuva Ayurveda Hospital (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.