BIOTEKE CORPORATION (WUXI) CO., LTD
⚠️ Moderate Risk
FEI: 3016837106 • Wuxi City, Jiangsu • CHINA
FEI Number
3016837106
Location
Wuxi City, Jiangsu
Country
CHINAAddress
4th Floor, D5 No.1719,Huishan Avenue, Wuxi City, 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
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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).
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 |
|---|---|---|---|
| 3/13/2023 | 80NNICONTAINER, SPECIMEN, NON-STERILE | 341REGISTERED | Division of Northern Border Imports (DNBI) |
| 12/30/2022 | 83PSZDEVICES DETECTING INFLUENZA A, B, AND C VIRUS ANTIGENS | Division of West Coast Imports (DWCI) | |
| 4/22/2021 | 83QJRREAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID | 508NO 510(K) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is BIOTEKE CORPORATION (WUXI) CO., LTD's FDA import refusal history?
BIOTEKE CORPORATION (WUXI) CO., LTD (FEI: 3016837106) has 3 FDA import refusal record(s) in our database, spanning from 4/22/2021 to 3/13/2023.
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. BIOTEKE CORPORATION (WUXI) CO., LTD's FEI number is 3016837106.
What types of violations has BIOTEKE CORPORATION (WUXI) CO., LTD received?
BIOTEKE CORPORATION (WUXI) CO., LTD has been cited for 3 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 BIOTEKE CORPORATION (WUXI) CO., LTD come from?
All FDA import refusal data for BIOTEKE CORPORATION (WUXI) 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.