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Maxgut Biochemical Co., Ltd

⚠️ Moderate Risk

FEI: 3004378760 • Taichung • TAIWAN

FEI

FEI Number

3004378760

📍

Location

Taichung

🇹🇼

Country

TAIWAN
🏢

Address

No, 2-1,Aly.1,Sec.1, Zhongxing Rd, Donghu Village, Taichung, , Taiwan

Moderate Risk

FDA Import Risk Assessment

40.2
LowModerateHighCritical

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

Statistics

18
Total Refusals
3
Unique Violations
7/3/2012
Latest Refusal
7/3/2012
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
47.4×30%
Recency
0.0×20%
Frequency
100.0×10%
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

47118×

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.

47318×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

47418×

COSMETLBLG

It appears the label does not bear the common or usual name of the cosmetic.

Refusal History

DateProductViolationsDivision
7/3/2012
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
471CSTIC LBLG
473LABELING
474COSMETLBLG
Division of Northeast Imports (DNEI)
7/3/2012
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
471CSTIC LBLG
473LABELING
474COSMETLBLG
Division of Northeast Imports (DNEI)
7/3/2012
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
471CSTIC LBLG
473LABELING
474COSMETLBLG
Division of Northeast Imports (DNEI)
7/3/2012
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
471CSTIC LBLG
473LABELING
474COSMETLBLG
Division of Northeast Imports (DNEI)
7/3/2012
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
471CSTIC LBLG
473LABELING
474COSMETLBLG
Division of Northeast Imports (DNEI)
7/3/2012
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
471CSTIC LBLG
473LABELING
474COSMETLBLG
Division of Northeast Imports (DNEI)
7/3/2012
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
471CSTIC LBLG
473LABELING
474COSMETLBLG
Division of Northeast Imports (DNEI)
7/3/2012
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
471CSTIC LBLG
473LABELING
474COSMETLBLG
Division of Northeast Imports (DNEI)
7/3/2012
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
471CSTIC LBLG
473LABELING
474COSMETLBLG
Division of Northeast Imports (DNEI)
7/3/2012
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
471CSTIC LBLG
473LABELING
474COSMETLBLG
Division of Northeast Imports (DNEI)
7/3/2012
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
471CSTIC LBLG
473LABELING
474COSMETLBLG
Division of Northeast Imports (DNEI)
7/3/2012
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
471CSTIC LBLG
473LABELING
474COSMETLBLG
Division of Northeast Imports (DNEI)
7/3/2012
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
471CSTIC LBLG
473LABELING
474COSMETLBLG
Division of Northeast Imports (DNEI)
7/3/2012
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
471CSTIC LBLG
473LABELING
474COSMETLBLG
Division of Northeast Imports (DNEI)
7/3/2012
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
471CSTIC LBLG
473LABELING
474COSMETLBLG
Division of Northeast Imports (DNEI)
7/3/2012
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
471CSTIC LBLG
473LABELING
474COSMETLBLG
Division of Northeast Imports (DNEI)
7/3/2012
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
471CSTIC LBLG
473LABELING
474COSMETLBLG
Division of Northeast Imports (DNEI)
7/3/2012
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
471CSTIC LBLG
473LABELING
474COSMETLBLG
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Maxgut Biochemical Co., Ltd's FDA import refusal history?

Maxgut Biochemical Co., Ltd (FEI: 3004378760) has 18 FDA import refusal record(s) in our database, spanning from 7/3/2012 to 7/3/2012.

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. Maxgut Biochemical Co., Ltd's FEI number is 3004378760.

What types of violations has Maxgut Biochemical Co., Ltd received?

Maxgut Biochemical Co., 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 Maxgut Biochemical Co., Ltd come from?

All FDA import refusal data for Maxgut Biochemical 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.