Guizhou Hongyu Pharmaceutical Co. Ltd.
⚠️ Moderate Risk
FEI: 3005065032 • Guiyang, Guizhou • CHINA
FEI Number
3005065032
Location
Guiyang, Guizhou
Country
CHINAAddress
State High-Tech Industry Development Zon, Shunxing Road, Guiyang, Guizhou, 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
LIST INGRE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
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).
UNSFDIETSP
The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
UNSFDIETLB
The article appears to be a dietary supplement or contain a dietary ingredient that presents a significant or unreasonable risk of illness or injury under the conditions of use set out in the labeling or, if none are set out in the labeling, under customary conditions of use.
Refusal History
Frequently Asked Questions
What is Guizhou Hongyu Pharmaceutical Co. Ltd.'s FDA import refusal history?
Guizhou Hongyu Pharmaceutical Co. Ltd. (FEI: 3005065032) has 2 FDA import refusal record(s) in our database, spanning from 1/12/2006 to 1/12/2006.
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. Guizhou Hongyu Pharmaceutical Co. Ltd.'s FEI number is 3005065032.
What types of violations has Guizhou Hongyu Pharmaceutical Co. Ltd. received?
Guizhou Hongyu Pharmaceutical Co. Ltd. has been cited for 4 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 Guizhou Hongyu Pharmaceutical Co. Ltd. come from?
All FDA import refusal data for Guizhou Hongyu 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.