Shanghai SynTheAll Pharmaceutical Co., Ltd.
⚠️ Moderate Risk
FEI: 3006337946 • Jinshan District, Shanghai • CHINA
FEI Number
3006337946
Location
Jinshan District, Shanghai
Country
CHINAAddress
No 9 Yuegong Road, , Jinshan District, Shanghai, 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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear 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).
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.
NO LICENSE
The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to bear adequate directions for use
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/27/2021 | 66YIY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of West Coast Imports (DWCI) | |
| 5/17/2021 | 66YIY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 2280DIRSEXMPT | Division of West Coast Imports (DWCI) |
| 10/10/2017 | 60TIA99ANTAGONIST, N.E.C. | 16DIRECTIONS | Division of Northeast Imports (DNEI) |
| 8/18/2015 | 65VIR05BENZOCTAMINE HCL (SEDATIVE) | 16DIRECTIONS | Atlanta District Office (ATL-DO) |
| 4/30/2014 | 61MIY99ANTI-CONVULSANT, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Shanghai SynTheAll Pharmaceutical Co., Ltd.'s FDA import refusal history?
Shanghai SynTheAll Pharmaceutical Co., Ltd. (FEI: 3006337946) has 5 FDA import refusal record(s) in our database, spanning from 4/30/2014 to 10/27/2021.
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. Shanghai SynTheAll Pharmaceutical Co., Ltd.'s FEI number is 3006337946.
What types of violations has Shanghai SynTheAll Pharmaceutical Co., Ltd. received?
Shanghai SynTheAll Pharmaceutical Co., Ltd. has been cited for 4 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 Shanghai SynTheAll Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for Shanghai 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.