Fujian Provincial Medicines & Health Products Imp & Exp Corp
⚠️ Moderate Risk
FEI: 3001321966 • Fuzhou, Fujian • CHINA
FEI Number
3001321966
Location
Fuzhou, Fujian
Country
CHINAAddress
Blk A 152 F/23, 154 Hu East Rd, Fuzhou, Fujian, 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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
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 Fujian Provincial Medicines & Health Products Imp & Exp Corp's FDA import refusal history?
Fujian Provincial Medicines & Health Products Imp & Exp Corp (FEI: 3001321966) has 1 FDA import refusal record(s) in our database, spanning from 1/10/2011 to 1/10/2011.
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. Fujian Provincial Medicines & Health Products Imp & Exp Corp's FEI number is 3001321966.
What types of violations has Fujian Provincial Medicines & Health Products Imp & Exp Corp received?
Fujian Provincial Medicines & Health Products Imp & Exp Corp has been cited for 3 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 Fujian Provincial Medicines & Health Products Imp & Exp Corp come from?
All FDA import refusal data for Fujian Provincial Medicines & Health Products Imp & Exp Corp 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.