WuXi AppTec (Shanghai) Co., Ltd.
⚠️ Moderate Risk
FEI: 3008361755 • Shanghai, Shanghai • CHINA
FEI Number
3008361755
Location
Shanghai, Shanghai
Country
CHINAAddress
Building 8, 299 Fute Middle Rd; Trade Zone, Shanghai, 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
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).
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/24/2020 | 80OFMPHLEBOTOMY BLOOD COLLECTION KIT | Division of Southeast Imports (DSEI) | |
| 2/23/2016 | 66YIY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 9/12/2012 | 62VIE99ANTI-VIRAL N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 9/12/2012 | 62VIE99ANTI-VIRAL N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 9/12/2012 | 62VIE99ANTI-VIRAL N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is WuXi AppTec (Shanghai) Co., Ltd.'s FDA import refusal history?
WuXi AppTec (Shanghai) Co., Ltd. (FEI: 3008361755) has 5 FDA import refusal record(s) in our database, spanning from 9/12/2012 to 1/24/2020.
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. WuXi AppTec (Shanghai) Co., Ltd.'s FEI number is 3008361755.
What types of violations has WuXi AppTec (Shanghai) Co., Ltd. received?
WuXi AppTec (Shanghai) 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 WuXi AppTec (Shanghai) Co., Ltd. come from?
All FDA import refusal data for WuXi AppTec (Shanghai) 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.