Xinxiang Tuoxin Pharmaceutical Co. Ltd
⚠️ High Risk
FEI: 3008259785 • Xinxiang, Henan • CHINA
FEI Number
3008259785
Location
Xinxiang, Henan
Country
CHINAAddress
Xinxiang Advanced, 398 Jingquan West Road; Technology District, Xinxiang, Henan, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/13/2025 | 56YOY99ANTIBIOTIC N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 5/23/2025 | 56YOY99ANTIBIOTIC N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/12/2023 | 61WOY10FLUCYTOSINE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 1/29/2021 | 62ICY99ANTI-NEOPLASTIC N.E.C. | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Xinxiang Tuoxin Pharmaceutical Co. Ltd's FDA import refusal history?
Xinxiang Tuoxin Pharmaceutical Co. Ltd (FEI: 3008259785) has 4 FDA import refusal record(s) in our database, spanning from 1/29/2021 to 6/13/2025.
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. Xinxiang Tuoxin Pharmaceutical Co. Ltd's FEI number is 3008259785.
What types of violations has Xinxiang Tuoxin Pharmaceutical Co. Ltd received?
Xinxiang Tuoxin Pharmaceutical Co. Ltd 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 Xinxiang Tuoxin Pharmaceutical Co. Ltd come from?
All FDA import refusal data for Xinxiang Tuoxin Pharmaceutical 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.