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Sheng Chang Pharmaceutical Company, Ltd.

⚠️ High Risk

FEI: 3011382182 • Taoyuan City • TAIWAN

FEI

FEI Number

3011382182

📍

Location

Taoyuan City

🇹🇼

Country

TAIWAN
🏢

Address

No. 436 Zhongli District, Minzu Road, Sec. 6, Taoyuan City, , Taiwan

High Risk

FDA Import Risk Assessment

53.4
LowModerateHighCritical

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

Statistics

6
Total Refusals
4
Unique Violations
2/28/2017
Latest Refusal
10/20/2016
Earliest Refusal

Score Breakdown

Violation Severity
95.0×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
60.0×10%
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

2512×

POISONOUS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:

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).

2411×

PESTICIDE

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a pesticide chemical residue, which causes the article to be adulterated within the meaning of section 402(a)(2)(B) of the FD&C Act. Bears or contains:

31201×

EPHEDALK

The product is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a dietary supplement or a dietary ingredient that appears to contain ephedrine alkaloids, which presents an unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling, or if no conditions of use are suggested in the labeling, under ordinary conditions of use.

Refusal History

DateProductViolationsDivision
2/28/2017
54FBR12GINSENG (HERBAL & BOTANICALS, NOT TEAS)
241PESTICIDE
Los Angeles District Office (LOS-DO)
10/20/2016
54FBR99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
3120EPHEDALK
Los Angeles District Office (LOS-DO)
10/20/2016
54FBR99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
251POISONOUS
Los Angeles District Office (LOS-DO)
10/20/2016
54FBR99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
251POISONOUS
Los Angeles District Office (LOS-DO)
10/20/2016
54FBR99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
10/20/2016
54FBR26STEPHANIA (FANGJI), (HERBAL & BOTANICALS, NOT TEAS)
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Sheng Chang Pharmaceutical Company, Ltd.'s FDA import refusal history?

Sheng Chang Pharmaceutical Company, Ltd. (FEI: 3011382182) has 6 FDA import refusal record(s) in our database, spanning from 10/20/2016 to 2/28/2017.

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. Sheng Chang Pharmaceutical Company, Ltd.'s FEI number is 3011382182.

What types of violations has Sheng Chang Pharmaceutical Company, Ltd. received?

Sheng Chang Pharmaceutical Company, 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 Sheng Chang Pharmaceutical Company, Ltd. come from?

All FDA import refusal data for Sheng Chang Pharmaceutical Company, 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.