ImportRefusal LogoImportRefusal

Ayur Herbals (PVT) Ltd

⚠️ Moderate Risk

FEI: 3011483968 • Shahjahanpur, Rajasthan • INDIA

FEI

FEI Number

3011483968

📍

Location

Shahjahanpur, Rajasthan

🇮🇳

Country

INDIA
🏢

Address

111, Milestone, Delhi - Jaipur N.H. 8, , Shahjahanpur, Rajasthan, India

Moderate Risk

FDA Import Risk Assessment

34.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
7/27/2017
Latest Refusal
7/27/2017
Earliest Refusal

Score Breakdown

Violation Severity
75.0×40%
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

22801×

DIRSEXMPT

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.

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
7/27/2017
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
2280DIRSEXMPT
75UNAPPROVED
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Ayur Herbals (PVT) Ltd's FDA import refusal history?

Ayur Herbals (PVT) Ltd (FEI: 3011483968) has 1 FDA import refusal record(s) in our database, spanning from 7/27/2017 to 7/27/2017.

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. Ayur Herbals (PVT) Ltd's FEI number is 3011483968.

What types of violations has Ayur Herbals (PVT) Ltd received?

Ayur Herbals (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 Ayur Herbals (PVT) Ltd come from?

All FDA import refusal data for Ayur Herbals (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.