Guangxi guihong natural healthy products co.ltd.
⚠️ Moderate Risk
FEI: 3004286164 • Guilin, Yanxizhuangzuzizhiqu • CHINA
FEI Number
3004286164
Location
Guilin, Yanxizhuangzuzizhiqu
Country
CHINAAddress
No. 38 Xiayanjiang,Lipu Countyseat,Guilin, , Guilin, Yanxizhuangzuzizhiqu, 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
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.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
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).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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 Guangxi guihong natural healthy products co.ltd.'s FDA import refusal history?
Guangxi guihong natural healthy products co.ltd. (FEI: 3004286164) has 2 FDA import refusal record(s) in our database, spanning from 12/18/2002 to 12/18/2002.
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. Guangxi guihong natural healthy products co.ltd.'s FEI number is 3004286164.
What types of violations has Guangxi guihong natural healthy products co.ltd. received?
Guangxi guihong natural healthy products co.ltd. has been cited for 5 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 Guangxi guihong natural healthy products co.ltd. come from?
All FDA import refusal data for Guangxi guihong natural healthy products 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.