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Dr. Sankunnis Ayurvedic Research Foundation Pvt Ltd

⚠️ High Risk

FEI: 3005939772 • Chennai, Tamil Nadu • INDIA

FEI

FEI Number

3005939772

📍

Location

Chennai, Tamil Nadu

🇮🇳

Country

INDIA
🏢

Address

11 East Park Street, , Chennai, Tamil Nadu, India

High Risk

FDA Import Risk Assessment

51.2
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

2
Total Refusals
2
Unique Violations
1/15/2025
Latest Refusal
6/17/2007
Earliest Refusal

Score Breakdown

Violation Severity
76.7×40%
Refusal Volume
17.7×30%
Recency
75.7×20%
Frequency
1.1×10%
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

752×

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).

1181×

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

DateProductViolationsDivision
1/15/2025
60LBJ99ANALGESIC, N.E.C.
75UNAPPROVED
Division of West Coast Imports (DWCI)
6/17/2007
66YIY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Dr. Sankunnis Ayurvedic Research Foundation Pvt Ltd's FDA import refusal history?

Dr. Sankunnis Ayurvedic Research Foundation Pvt Ltd (FEI: 3005939772) has 2 FDA import refusal record(s) in our database, spanning from 6/17/2007 to 1/15/2025.

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. Dr. Sankunnis Ayurvedic Research Foundation Pvt Ltd's FEI number is 3005939772.

What types of violations has Dr. Sankunnis Ayurvedic Research Foundation Pvt Ltd received?

Dr. Sankunnis Ayurvedic Research Foundation 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 Dr. Sankunnis Ayurvedic Research Foundation Pvt Ltd come from?

All FDA import refusal data for Dr. Sankunnis Ayurvedic Research Foundation 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.