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Shantou S.E.Z Baojie Industry Co., Ltd.

⚠️ Moderate Risk

FEI: 3016787260 • Shantou, Guangdong • CHINA

FEI

FEI Number

3016787260

📍

Location

Shantou, Guangdong

🇨🇳

Country

CHINA
🏢

Address

Sihuang Road Lugang, Xiashanzhen Chaonan, Shantou, Guangdong, China

Moderate Risk

FDA Import Risk Assessment

43.0
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
9/4/2020
Latest Refusal
6/16/2010
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
2.9×10%
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

753×

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).

Refusal History

DateProductViolationsDivision
9/4/2020
62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL)
75UNAPPROVED
Division of Southwest Imports (DSWI)
9/4/2020
62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL)
75UNAPPROVED
Division of Southwest Imports (DSWI)
6/16/2010
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
75UNAPPROVED
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Shantou S.E.Z Baojie Industry Co., Ltd.'s FDA import refusal history?

Shantou S.E.Z Baojie Industry Co., Ltd. (FEI: 3016787260) has 3 FDA import refusal record(s) in our database, spanning from 6/16/2010 to 9/4/2020.

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. Shantou S.E.Z Baojie Industry Co., Ltd.'s FEI number is 3016787260.

What types of violations has Shantou S.E.Z Baojie Industry Co., Ltd. received?

Shantou S.E.Z Baojie Industry Co., Ltd. has been cited for 1 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 Shantou S.E.Z Baojie Industry Co., Ltd. come from?

All FDA import refusal data for Shantou S.E.Z Baojie Industry 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.