ImportRefusal LogoImportRefusal

Soapberry Biotech Progress Co., Ltd.

⚠️ Moderate Risk

FEI: 3012315327 • Tainan City • TAIWAN

FEI

FEI Number

3012315327

📍

Location

Tainan City

🇹🇼

Country

TAIWAN
🏢

Address

No. 62-18 Anding, Youche, Nan-An Village, Tainan City, , Taiwan

Moderate Risk

FDA Import Risk Assessment

45.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
6/9/2020
Latest Refusal
11/26/2019
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

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
6/9/2020
53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
75UNAPPROVED
Division of West Coast Imports (DWCI)
6/9/2020
53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
75UNAPPROVED
Division of West Coast Imports (DWCI)
11/26/2019
53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING)
75UNAPPROVED
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is Soapberry Biotech Progress Co., Ltd.'s FDA import refusal history?

Soapberry Biotech Progress Co., Ltd. (FEI: 3012315327) has 3 FDA import refusal record(s) in our database, spanning from 11/26/2019 to 6/9/2020.

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. Soapberry Biotech Progress Co., Ltd.'s FEI number is 3012315327.

What types of violations has Soapberry Biotech Progress Co., Ltd. received?

Soapberry Biotech Progress 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 Soapberry Biotech Progress Co., Ltd. come from?

All FDA import refusal data for Soapberry Biotech Progress 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.