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Shie Ching Hsien Chemical Industrial Co Ltd

⚠️ Moderate Risk

FEI: 3003436727 • Kaoshing • TAIWAN

FEI

FEI Number

3003436727

📍

Location

Kaoshing

🇹🇼

Country

TAIWAN
🏢

Address

518 Chung Cheng Rd, , Kaoshing, , Taiwan

Moderate Risk

FDA Import Risk Assessment

31.0
LowModerateHighCritical

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

Statistics

6
Total Refusals
3
Unique Violations
1/26/2009
Latest Refusal
5/21/2003
Earliest Refusal

Score Breakdown

Violation Severity
51.4×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
10.5×10%
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

4714×

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.

752×

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).

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.

Refusal History

DateProductViolationsDivision
1/26/2009
53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
333LACKS FIRM
75UNAPPROVED
Seattle District Office (SEA-DO)
5/21/2003
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
5/21/2003
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
5/21/2003
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
5/21/2003
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
5/21/2003
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Shie Ching Hsien Chemical Industrial Co Ltd's FDA import refusal history?

Shie Ching Hsien Chemical Industrial Co Ltd (FEI: 3003436727) has 6 FDA import refusal record(s) in our database, spanning from 5/21/2003 to 1/26/2009.

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. Shie Ching Hsien Chemical Industrial Co Ltd's FEI number is 3003436727.

What types of violations has Shie Ching Hsien Chemical Industrial Co Ltd received?

Shie Ching Hsien Chemical Industrial 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 Shie Ching Hsien Chemical Industrial Co Ltd come from?

All FDA import refusal data for Shie Ching Hsien Chemical 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.