ImportRefusal LogoImportRefusal

Foshan Hi charm Biotechnology Co., Ltd.

⚠️ High Risk

FEI: 3032080170 • Foshan, Guangdong • CHINA

FEI

FEI Number

3032080170

📍

Location

Foshan, Guangdong

🇨🇳

Country

CHINA
🏢

Address

No.2 Zhangling Road, LubaoTown, Sanshui District, Foshan, Guangdong, China

High Risk

FDA Import Risk Assessment

59.7
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
11/17/2025
Latest Refusal
11/17/2025
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
96.7×20%
Frequency
10.0×10%
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

751×

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
11/17/2025
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Foshan Hi charm Biotechnology Co., Ltd.'s FDA import refusal history?

Foshan Hi charm Biotechnology Co., Ltd. (FEI: 3032080170) has 1 FDA import refusal record(s) in our database, spanning from 11/17/2025 to 11/17/2025.

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. Foshan Hi charm Biotechnology Co., Ltd.'s FEI number is 3032080170.

What types of violations has Foshan Hi charm Biotechnology Co., Ltd. received?

Foshan Hi charm Biotechnology 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 Foshan Hi charm Biotechnology Co., Ltd. come from?

All FDA import refusal data for Foshan Hi charm Biotechnology 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.