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Guangzhou Haishi Biological Technology Co,Ltd.

⚠️ High Risk

FEI: 3021683994 • Guangzhou, Guangdong • CHINA

FEI

FEI Number

3021683994

📍

Location

Guangzhou, Guangdong

🇨🇳

Country

CHINA
🏢

Address

Building 3, New Industrial Area of No. 11 She, Xiamao Village, Baiyun District, Guangzhou, Guangdong, China

High Risk

FDA Import Risk Assessment

58.1
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
6/25/2025
Latest Refusal
6/25/2025
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
88.9×20%
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
6/25/2025
66PBY99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Guangzhou Haishi Biological Technology Co,Ltd.'s FDA import refusal history?

Guangzhou Haishi Biological Technology Co,Ltd. (FEI: 3021683994) has 1 FDA import refusal record(s) in our database, spanning from 6/25/2025 to 6/25/2025.

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. Guangzhou Haishi Biological Technology Co,Ltd.'s FEI number is 3021683994.

What types of violations has Guangzhou Haishi Biological Technology Co,Ltd. received?

Guangzhou Haishi Biological Technology 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 Guangzhou Haishi Biological Technology Co,Ltd. come from?

All FDA import refusal data for Guangzhou Haishi Biological Technology 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.