Safecare Biotech (Hangzhou) Co.,Ltd
⚠️ High Risk
FEI: 3017040656 • Hangzhou, Zhejiang • CHINA
FEI Number
3017040656
Location
Hangzhou, Zhejiang
Country
CHINAAddress
Building 2/203, No. 18 Haishu Road; Cangqian Sub-District Yuhang, Hangzhou, Zhejiang, 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
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).
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/5/2025 | 83QWBOVER-THE-COUNTER MOLECULAR TEST TO DETECT SARS-COV-2 | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 3/20/2025 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | Division of Southeast Imports (DSEI) | |
| 2/9/2022 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Northern Border Imports (DNBI) |
| 5/4/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | Division of Southeast Imports (DSEI) | |
| 10/26/2016 | 91NFWTEST, CANNABINOID, OVER THE COUNTER | 333LACKS FIRM | Division of Southeast Imports (DSEI) |
| 9/27/2016 | 91ORABREAST MILK-ALCOHOL TEST SYSTEM | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Safecare Biotech (Hangzhou) Co.,Ltd's FDA import refusal history?
Safecare Biotech (Hangzhou) Co.,Ltd (FEI: 3017040656) has 6 FDA import refusal record(s) in our database, spanning from 9/27/2016 to 12/5/2025.
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. Safecare Biotech (Hangzhou) Co.,Ltd's FEI number is 3017040656.
What types of violations has Safecare Biotech (Hangzhou) Co.,Ltd received?
Safecare Biotech (Hangzhou) Co.,Ltd has been cited for 5 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 Safecare Biotech (Hangzhou) Co.,Ltd come from?
All FDA import refusal data for Safecare Biotech (Hangzhou) 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.