GUANGZHOU HONGLI PHAMACEUTICAL CO.,
⚠️ High Risk
FEI: 3038354568 • Guangzhou, Guangdong • CHINA
FEI Number
3038354568
Location
Guangzhou, Guangdong
Country
CHINAAddress
Room 302, Junhe Street; Baiyun District, Guangzhou, Guangdong, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
Frequently Asked Questions
What is GUANGZHOU HONGLI PHAMACEUTICAL CO.,'s FDA import refusal history?
GUANGZHOU HONGLI PHAMACEUTICAL CO., (FEI: 3038354568) has 2 FDA import refusal record(s) in our database, spanning from 7/22/2025 to 7/22/2025.
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 HONGLI PHAMACEUTICAL CO.,'s FEI number is 3038354568.
What types of violations has GUANGZHOU HONGLI PHAMACEUTICAL CO., received?
GUANGZHOU HONGLI PHAMACEUTICAL CO., 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 HONGLI PHAMACEUTICAL CO., come from?
All FDA import refusal data for GUANGZHOU HONGLI PHAMACEUTICAL CO., 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.