Guangzhou Pluslife Biotech Co., Ltd.
⚠️ High Risk
FEI: 3037392657 • Guangzhou • CHINA
FEI Number
3037392657
Location
Guangzhou
Country
CHINAAddress
Room 402, 6 Lianhuayan Road, Huangpu District, Guangzhou, , 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
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.
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.
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 |
|---|---|---|---|
| 11/5/2025 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | Division of Southeast Imports (DSEI) | |
| 6/13/2025 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | Division of Southeast Imports (DSEI) | |
| 5/9/2025 | 83QWBOVER-THE-COUNTER MOLECULAR TEST TO DETECT SARS-COV-2 | Division of Southeast Imports (DSEI) | |
| 4/23/2025 | 83QLWCOVID-19 TEST HOME COLLECTION KIT DEVICES | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Guangzhou Pluslife Biotech Co., Ltd.'s FDA import refusal history?
Guangzhou Pluslife Biotech Co., Ltd. (FEI: 3037392657) has 4 FDA import refusal record(s) in our database, spanning from 4/23/2025 to 11/5/2025.
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. Guangzhou Pluslife Biotech Co., Ltd.'s FEI number is 3037392657.
What types of violations has Guangzhou Pluslife Biotech Co., Ltd. received?
Guangzhou Pluslife Biotech 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 Guangzhou Pluslife Biotech Co., Ltd. come from?
All FDA import refusal data for Guangzhou Pluslife Biotech 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.