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Hindustan Unileaver Limited

⚠️ Moderate Risk

FEI: 3007807486 • Uttarakhand • INDIA

FEI

FEI Number

3007807486

📍

Location

Uttarakhand

🇮🇳

Country

INDIA
🏢

Address

Unit No. 3, Plot No. 1, Sector, , Uttarakhand, , India

Moderate Risk

FDA Import Risk Assessment

33.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
3/28/2014
Latest Refusal
3/28/2014
Earliest Refusal

Score Breakdown

Violation Severity
73.3×40%
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

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

3091×

FORBIDDEN

The article is subject to refusal of admission pursuant to Section 801(a)(2) in that it appears to be forbidden or restricted in sale in the country in which it was produced or from which it was exported.

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
3/28/2014
65GBY99PIGMENTATION AGENT N.E.C.
16DIRECTIONS
309FORBIDDEN
75UNAPPROVED
New England District Office (NWE-DO)

Frequently Asked Questions

What is Hindustan Unileaver Limited's FDA import refusal history?

Hindustan Unileaver Limited (FEI: 3007807486) has 1 FDA import refusal record(s) in our database, spanning from 3/28/2014 to 3/28/2014.

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. Hindustan Unileaver Limited's FEI number is 3007807486.

What types of violations has Hindustan Unileaver Limited received?

Hindustan Unileaver Limited 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 Hindustan Unileaver Limited come from?

All FDA import refusal data for Hindustan Unileaver Limited 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.