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Uniliver Thai Holding Co.,Ltd

⚠️ Moderate Risk

FEI: 3007650246 • Lat Krabang, Bangkok • THAILAND

FEI

FEI Number

3007650246

📍

Location

Lat Krabang, Bangkok

🇹🇭

Country

THAILAND
🏢

Address

63 Nikomausahagum, , Lat Krabang, Bangkok, Thailand

Moderate Risk

FDA Import Risk Assessment

26.9
LowModerateHighCritical

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

Statistics

2
Total Refusals
4
Unique Violations
1/6/2012
Latest Refusal
9/29/2010
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
15.7×10%
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

1182×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

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.

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

4831×

DRUG NAME

The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.

Refusal History

DateProductViolationsDivision
1/6/2012
66YC99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
118NOT LISTED
16DIRECTIONS
483DRUG NAME
New York District Office (NYK-DO)
9/29/2010
63RAY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)
118NOT LISTED
472NO ENGLISH
New York District Office (NYK-DO)

Frequently Asked Questions

What is Uniliver Thai Holding Co.,Ltd's FDA import refusal history?

Uniliver Thai Holding Co.,Ltd (FEI: 3007650246) has 2 FDA import refusal record(s) in our database, spanning from 9/29/2010 to 1/6/2012.

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. Uniliver Thai Holding Co.,Ltd's FEI number is 3007650246.

What types of violations has Uniliver Thai Holding Co.,Ltd received?

Uniliver Thai Holding Co.,Ltd 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 Uniliver Thai Holding Co.,Ltd come from?

All FDA import refusal data for Uniliver Thai Holding Co.,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.