Kunshan Chemicals & Pharmaceutical Factory
⚠️ Moderate Risk
FEI: 3002931612 • Jiangsu • CHINA
FEI Number
3002931612
Location
Jiangsu
Country
CHINAAddress
No 242 Kun Tai Road, Kunshan City, 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
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
Frequently Asked Questions
What is Kunshan Chemicals & Pharmaceutical Factory's FDA import refusal history?
Kunshan Chemicals & Pharmaceutical Factory (FEI: 3002931612) has 2 FDA import refusal record(s) in our database, spanning from 11/20/2008 to 10/21/2009.
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. Kunshan Chemicals & Pharmaceutical Factory's FEI number is 3002931612.
What types of violations has Kunshan Chemicals & Pharmaceutical Factory received?
Kunshan Chemicals & Pharmaceutical Factory has been cited for 1 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 Kunshan Chemicals & Pharmaceutical Factory come from?
All FDA import refusal data for Kunshan Chemicals & 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.