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ADVAITA PHARMA

⚠️ High Risk

FEI: 3031228520 • Del Valle, Tlaxcala • MEXICO

FEI

FEI Number

3031228520

📍

Location

Del Valle, Tlaxcala

🇲🇽

Country

MEXICO
🏢

Address

Adolfo Prieto 1427, Tlaxcala, Del Valle, Tlaxcala, Mexico

High Risk

FDA Import Risk Assessment

56.1
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/23/2024
Latest Refusal
12/23/2024
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
78.7×20%
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
12/23/2024
54YCT99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is ADVAITA PHARMA's FDA import refusal history?

ADVAITA PHARMA (FEI: 3031228520) has 1 FDA import refusal record(s) in our database, spanning from 12/23/2024 to 12/23/2024.

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. ADVAITA PHARMA's FEI number is 3031228520.

What types of violations has ADVAITA PHARMA received?

ADVAITA PHARMA 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 ADVAITA PHARMA come from?

All FDA import refusal data for ADVAITA PHARMA 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.