Changzhou Golden Bright Pharmaceutical Factory
⚠️ Moderate Risk
FEI: 3016565679 • Changzhou, Jiangsu • CHINA
FEI Number
3016565679
Location
Changzhou, Jiangsu
Country
CHINAAddress
Gongyeyuan, No. 678 Zhuzhuang; Jintan, Changzhou, Jiangsu, 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).
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
Refusal History
Frequently Asked Questions
What is Changzhou Golden Bright Pharmaceutical Factory's FDA import refusal history?
Changzhou Golden Bright Pharmaceutical Factory (FEI: 3016565679) has 1 FDA import refusal record(s) in our database, spanning from 3/30/2021 to 3/30/2021.
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. Changzhou Golden Bright Pharmaceutical Factory's FEI number is 3016565679.
What types of violations has Changzhou Golden Bright Pharmaceutical Factory received?
Changzhou Golden Bright Pharmaceutical Factory 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 Changzhou Golden Bright Pharmaceutical Factory come from?
All FDA import refusal data for Changzhou Golden Bright Pharmaceutical Factory 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.