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ADISUTRA AYURVEDS LLP

⚠️ Moderate Risk

FEI: 3033709341 • Maharashtra • INDIA

FEI

FEI Number

3033709341

📍

Location

Maharashtra

🇮🇳

Country

INDIA
🏢

Address

A-1801 Gagan Unnatii, K, , Maharashtra, , India

Moderate Risk

FDA Import Risk Assessment

40.4
LowModerateHighCritical

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

Statistics

1
Total Refusals
4
Unique Violations
1/16/2025
Latest Refusal
1/16/2025
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
80.0×20%
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

23001×

DIETARYLBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.

3211×

LACKS N/C

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.

4821×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

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
1/16/2025
54BDY99MINERAL N.E.C.
2300DIETARYLBL
321LACKS N/C
482NUTRIT LBL
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is ADISUTRA AYURVEDS LLP's FDA import refusal history?

ADISUTRA AYURVEDS LLP (FEI: 3033709341) has 1 FDA import refusal record(s) in our database, spanning from 1/16/2025 to 1/16/2025.

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. ADISUTRA AYURVEDS LLP's FEI number is 3033709341.

What types of violations has ADISUTRA AYURVEDS LLP received?

ADISUTRA AYURVEDS LLP has been cited for 4 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 ADISUTRA AYURVEDS LLP come from?

All FDA import refusal data for ADISUTRA AYURVEDS LLP 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.