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Kairali Ayurvedic Products Private Limited

⚠️ Moderate Risk

FEI: 3012342175 • Dhalavaipalayam, Tamil Nadu • INDIA

FEI

FEI Number

3012342175

📍

Location

Dhalavaipalayam, Tamil Nadu

🇮🇳

Country

INDIA
🏢

Address

121/1 - A1 Karatupalayam Village, Samathur, Dhalavaipalayam, Tamil Nadu, India

Moderate Risk

FDA Import Risk Assessment

47.1
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
2/15/2022
Latest Refusal
2/15/2022
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
6.8×20%
Frequency
30.0×10%
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

753×

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
2/15/2022
65PDA99REGULATOR N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
2/15/2022
65PDA99REGULATOR N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
2/15/2022
65PDA99REGULATOR N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Kairali Ayurvedic Products Private Limited's FDA import refusal history?

Kairali Ayurvedic Products Private Limited (FEI: 3012342175) has 3 FDA import refusal record(s) in our database, spanning from 2/15/2022 to 2/15/2022.

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. Kairali Ayurvedic Products Private Limited's FEI number is 3012342175.

What types of violations has Kairali Ayurvedic Products Private Limited received?

Kairali Ayurvedic Products Private Limited 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 Kairali Ayurvedic Products Private Limited come from?

All FDA import refusal data for Kairali Ayurvedic Products Private 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.