GUANGZHOU KANGYUAN INT BIOTECH CO L
⚠️ Moderate Risk
FEI: 3030343532 • Guangzhou, Guangdong • CHINA
FEI Number
3030343532
Location
Guangzhou, Guangdong
Country
CHINAAddress
Bldg 2, No 3 Long He Middle Rd, Guangzhou, Guangdong, China
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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
Frequently Asked Questions
What is GUANGZHOU KANGYUAN INT BIOTECH CO L's FDA import refusal history?
GUANGZHOU KANGYUAN INT BIOTECH CO L (FEI: 3030343532) has 1 FDA import refusal record(s) in our database, spanning from 2/22/2024 to 2/22/2024.
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 KANGYUAN INT BIOTECH CO L's FEI number is 3030343532.
What types of violations has GUANGZHOU KANGYUAN INT BIOTECH CO L received?
GUANGZHOU KANGYUAN INT BIOTECH CO L has been cited for 2 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 KANGYUAN INT BIOTECH CO L come from?
All FDA import refusal data for GUANGZHOU KANGYUAN INT BIOTECH CO L 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.