Tianjin Zhong Xin Pharmaceutical
⚠️ Moderate Risk
FEI: 3002808515 • Tianjin • CHINA
FEI Number
3002808515
Location
Tianjin
Country
CHINAAddress
Xin Xin Pharmaceutical Manufactory, Chenglin Zhuang Industrial Area, Tianjin, , 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).
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).
Refusal History
Frequently Asked Questions
What is Tianjin Zhong Xin Pharmaceutical's FDA import refusal history?
Tianjin Zhong Xin Pharmaceutical (FEI: 3002808515) has 3 FDA import refusal record(s) in our database, spanning from 3/7/2002 to 2/18/2003.
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. Tianjin Zhong Xin Pharmaceutical's FEI number is 3002808515.
What types of violations has Tianjin Zhong Xin Pharmaceutical received?
Tianjin Zhong Xin Pharmaceutical 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 Tianjin Zhong Xin Pharmaceutical come from?
All FDA import refusal data for Tianjin Zhong Xin Pharmaceutical 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.