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Ni Hau Industrial Co Ltd

⚠️ High Risk

FEI: 3003305649 • Tainan City • TAIWAN

FEI

FEI Number

3003305649

📍

Location

Tainan City

🇹🇼

Country

TAIWAN
🏢

Address

Alley 125 Lane 318, No. 15 An Ho Rd, Sec. 2, Tainan City, , Taiwan

High Risk

FDA Import Risk Assessment

51.5
LowModerateHighCritical

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

Statistics

49
Total Refusals
8
Unique Violations
8/9/2016
Latest Refusal
1/2/2004
Earliest Refusal

Score Breakdown

Violation Severity
71.8×40%
Refusal Volume
62.9×30%
Recency
0.0×20%
Frequency
38.9×10%
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

19732×

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).

19813×

COLOR LBLG

The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.

2744×

COLOR LBLG

The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.

4752×

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.

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.

3331×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

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.

1181×

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).

Refusal History

DateProductViolationsDivision
8/9/2016
53GC12CHILDREN NOVELTY LIPGLOSS
197COSM COLOR
Los Angeles District Office (LOS-DO)
8/9/2016
53GC12CHILDREN NOVELTY LIPGLOSS
197COSM COLOR
Los Angeles District Office (LOS-DO)
3/30/2016
53GD05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES)
197COSM COLOR
New York District Office (NYK-DO)
3/22/2016
53GC99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C.
197COSM COLOR
New York District Office (NYK-DO)
3/10/2016
53GC99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C.
197COSM COLOR
New York District Office (NYK-DO)
12/17/2015
53GC12CHILDREN NOVELTY LIPGLOSS
197COSM COLOR
Division of Northeast Imports (DNEI)
10/20/2015
53GY12CHILDREN NOVELTY LIPGLOSS
475COSMETLBLG
San Francisco District Office (SAN-DO)
7/10/2015
53GY12CHILDREN NOVELTY LIPGLOSS
197COSM COLOR
198COLOR LBLG
San Francisco District Office (SAN-DO)
4/29/2015
53GK05LIPSTICK (MAKEUP PREPARATIONS, NOT FOR EYES)
198COLOR LBLG
New York District Office (NYK-DO)
3/23/2015
53GD99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C.
197COSM COLOR
Los Angeles District Office (LOS-DO)
3/23/2015
53GD99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C.
197COSM COLOR
Los Angeles District Office (LOS-DO)
3/23/2015
53GD99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C.
197COSM COLOR
Los Angeles District Office (LOS-DO)
3/23/2015
53GD99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C.
197COSM COLOR
Los Angeles District Office (LOS-DO)
3/23/2015
53GD99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C.
197COSM COLOR
Los Angeles District Office (LOS-DO)
3/23/2015
53GD99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C.
197COSM COLOR
Los Angeles District Office (LOS-DO)
3/23/2015
53GY99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C.
197COSM COLOR
Los Angeles District Office (LOS-DO)
3/23/2015
53GY99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C.
197COSM COLOR
Los Angeles District Office (LOS-DO)
3/23/2015
53GY99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C.
197COSM COLOR
Los Angeles District Office (LOS-DO)
3/23/2015
53GY99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C.
197COSM COLOR
Los Angeles District Office (LOS-DO)
3/23/2015
53GY99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C.
197COSM COLOR
Los Angeles District Office (LOS-DO)
3/23/2015
53GY99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C.
197COSM COLOR
Los Angeles District Office (LOS-DO)
3/16/2015
53GD99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C.
197COSM COLOR
Los Angeles District Office (LOS-DO)
3/16/2015
53GD99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C.
197COSM COLOR
Los Angeles District Office (LOS-DO)
3/16/2015
53GD99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C.
197COSM COLOR
Los Angeles District Office (LOS-DO)
3/16/2015
53GD99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C.
197COSM COLOR
Los Angeles District Office (LOS-DO)
3/16/2015
53GD99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C.
197COSM COLOR
Los Angeles District Office (LOS-DO)
3/16/2015
53GD99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C.
197COSM COLOR
Los Angeles District Office (LOS-DO)
10/10/2014
53GC99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C.
274COLOR LBLG
New York District Office (NYK-DO)
10/10/2014
53GC99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C.
274COLOR LBLG
New York District Office (NYK-DO)
10/10/2014
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
274COLOR LBLG
New York District Office (NYK-DO)
10/10/2014
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
274COLOR LBLG
New York District Office (NYK-DO)
10/10/2014
53GC99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C.
198COLOR LBLG
New York District Office (NYK-DO)
10/10/2014
53CC99OTHER EYE MAKEUP PREPARATIONS, N.E.C.
198COLOR LBLG
New York District Office (NYK-DO)
10/10/2014
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
198COLOR LBLG
New York District Office (NYK-DO)
10/10/2014
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
198COLOR LBLG
New York District Office (NYK-DO)
10/10/2014
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
198COLOR LBLG
New York District Office (NYK-DO)
10/10/2014
53GC99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C.
198COLOR LBLG
New York District Office (NYK-DO)
10/10/2014
53GC99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C.
198COLOR LBLG
New York District Office (NYK-DO)
10/10/2014
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
198COLOR LBLG
New York District Office (NYK-DO)
10/10/2014
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
198COLOR LBLG
New York District Office (NYK-DO)
9/26/2014
53GY12CHILDREN NOVELTY LIPGLOSS
197COSM COLOR
198COLOR LBLG
San Francisco District Office (SAN-DO)
8/29/2014
53GY12CHILDREN NOVELTY LIPGLOSS
197COSM COLOR
471CSTIC LBLG
475COSMETLBLG
San Francisco District Office (SAN-DO)
4/24/2014
53GC99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C.
197COSM COLOR
New York District Office (NYK-DO)
4/24/2014
53GC99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C.
197COSM COLOR
New York District Office (NYK-DO)
4/24/2014
53GC99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C.
197COSM COLOR
New York District Office (NYK-DO)
4/24/2014
53GC99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C.
197COSM COLOR
New York District Office (NYK-DO)
5/15/2012
53GH02FACE POWDERS (MAKEUP PREPARATIONS, NOT FOR EYES)
198COLOR LBLG
Cincinnati District Office (CIN-DO)
6/29/2011
53GC99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C.
197COSM COLOR
Chicago District Office (CHI-DO)
1/2/2004
66PAJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
118NOT LISTED
16DIRECTIONS
333LACKS FIRM
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Ni Hau Industrial Co Ltd's FDA import refusal history?

Ni Hau Industrial Co Ltd (FEI: 3003305649) has 49 FDA import refusal record(s) in our database, spanning from 1/2/2004 to 8/9/2016.

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. Ni Hau Industrial Co Ltd's FEI number is 3003305649.

What types of violations has Ni Hau Industrial Co Ltd received?

Ni Hau Industrial Co Ltd has been cited for 8 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 Ni Hau Industrial Co Ltd come from?

All FDA import refusal data for Ni Hau Industrial 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.