Changzhou SynTheAll Pharmaceutical Co., Ltd
⚠️ Moderate Risk
FEI: 3012897823 • Changzhou, Jiangsu • CHINA
FEI Number
3012897823
Location
Changzhou, Jiangsu
Country
CHINAAddress
No. 589 North Yulong Road, , 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
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.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/25/2022 | 62IIS99ANTI-NEOPLASTIC N.E.C. | Division of West Coast Imports (DWCI) | |
| 7/2/2021 | 66YIY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 2280DIRSEXMPT | Division of West Coast Imports (DWCI) |
| 6/23/2021 | 66YIY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 2280DIRSEXMPT | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Changzhou SynTheAll Pharmaceutical Co., Ltd's FDA import refusal history?
Changzhou SynTheAll Pharmaceutical Co., Ltd (FEI: 3012897823) has 3 FDA import refusal record(s) in our database, spanning from 6/23/2021 to 4/25/2022.
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 SynTheAll Pharmaceutical Co., Ltd's FEI number is 3012897823.
What types of violations has Changzhou SynTheAll Pharmaceutical Co., Ltd received?
Changzhou SynTheAll Pharmaceutical Co., Ltd 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 SynTheAll Pharmaceutical Co., Ltd come from?
All FDA import refusal data for Changzhou SynTheAll 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.