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SANKHLA MEHANDI UDHYOG

⚠️ Moderate Risk

FEI: 3012799388 • RAJASTHAN • INDIA

FEI

FEI Number

3012799388

📍

Location

RAJASTHAN

🇮🇳

Country

INDIA
🏢

Address

H-115,G-116-A INDUSTRIA, 3RD PHASE SOJAT CITY, DISTRICT P, RAJASTHAN, , India

Moderate Risk

FDA Import Risk Assessment

49.6
LowModerateHighCritical

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

Statistics

5
Total Refusals
2
Unique Violations
6/12/2018
Latest Refusal
6/12/2018
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
50.0×10%
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

754×

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).

1971×

COSM COLOR

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).

Refusal History

DateProductViolationsDivision
6/12/2018
53FH01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI
197COSM COLOR
Division of Northern Border Imports (DNBI)
6/12/2018
66VAY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Northern Border Imports (DNBI)
6/12/2018
53EH01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING)
75UNAPPROVED
Division of Northern Border Imports (DNBI)
6/12/2018
53FH01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI
75UNAPPROVED
Division of Northern Border Imports (DNBI)
6/12/2018
66VAR99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is SANKHLA MEHANDI UDHYOG's FDA import refusal history?

SANKHLA MEHANDI UDHYOG (FEI: 3012799388) has 5 FDA import refusal record(s) in our database, spanning from 6/12/2018 to 6/12/2018.

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. SANKHLA MEHANDI UDHYOG's FEI number is 3012799388.

What types of violations has SANKHLA MEHANDI UDHYOG received?

SANKHLA MEHANDI UDHYOG 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 SANKHLA MEHANDI UDHYOG come from?

All FDA import refusal data for SANKHLA MEHANDI UDHYOG 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.