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Azafran Innovacion Ltd.

⚠️ Moderate Risk

FEI: 3014990428 • Sanand, Gujarat • INDIA

FEI

FEI Number

3014990428

📍

Location

Sanand, Gujarat

🇮🇳

Country

INDIA
🏢

Address

507 508 Plot 506, Village - Vinchhiya, Sanand, Gujarat, India

Moderate Risk

FDA Import Risk Assessment

38.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
12/26/2023
Latest Refusal
12/26/2023
Earliest Refusal

Score Breakdown

Violation Severity
56.7×40%
Refusal Volume
11.2×30%
Recency
58.6×20%
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

4711×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

4751×

COSMETLBLG

It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.

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
12/26/2023
53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
471CSTIC LBLG
475COSMETLBLG
75UNAPPROVED
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Azafran Innovacion Ltd.'s FDA import refusal history?

Azafran Innovacion Ltd. (FEI: 3014990428) has 1 FDA import refusal record(s) in our database, spanning from 12/26/2023 to 12/26/2023.

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. Azafran Innovacion Ltd.'s FEI number is 3014990428.

What types of violations has Azafran Innovacion Ltd. received?

Azafran Innovacion Ltd. has been cited for 3 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 Azafran Innovacion Ltd. come from?

All FDA import refusal data for Azafran Innovacion 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.