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Guangzhou Huanye Pharmaceutical Co., Ltd.

⚠️ Moderate Risk

FEI: 3004682934 • Guangzhou, Yandong • CHINA

FEI

FEI Number

3004682934

📍

Location

Guangzhou, Yandong

🇨🇳

Country

CHINA
🏢

Address

195 Fangcun Dadao E, , Guangzhou, Yandong, China

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
7/1/2009
Latest Refusal
7/1/2009
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

Refusal History

DateProductViolationsDivision
7/1/2009
66BAR99STIMULANT N.E.C.
16DIRECTIONS
Minneapolis District Office (MIN-DO)

Frequently Asked Questions

What is Guangzhou Huanye Pharmaceutical Co., Ltd.'s FDA import refusal history?

Guangzhou Huanye Pharmaceutical Co., Ltd. (FEI: 3004682934) has 1 FDA import refusal record(s) in our database, spanning from 7/1/2009 to 7/1/2009.

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 Huanye Pharmaceutical Co., Ltd.'s FEI number is 3004682934.

What types of violations has Guangzhou Huanye Pharmaceutical Co., Ltd. received?

Guangzhou Huanye Pharmaceutical 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 Huanye Pharmaceutical Co., Ltd. come from?

All FDA import refusal data for Guangzhou Huanye Pharmaceutical 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.