Guangzhou Xiubo Medical Equipment Co. Ltd
⚠️ High Risk
FEI: 3010976338 • Guangzhou, Guangdong • CHINA
FEI Number
3010976338
Location
Guangzhou, Guangdong
Country
CHINAAddress
No. 22 Tian Yuan Road, Baiyun District, , Guangzhou, Guangdong, 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 PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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.
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).
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.
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
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
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
INSANITARY
The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/25/2023 | 53LH03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 8/29/2022 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 8/29/2022 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 9/11/2018 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 237NO PMA | Division of Southeast Imports (DSEI) |
| 8/30/2018 | 53LH06MOISTURIZING (SKIN CARE PREPARATIONS) | Division of Southeast Imports (DSEI) | |
| 6/1/2018 | 87MOZACID, HYALURONIC, INTRAARTICULAR | 237NO PMA | Division of Southeast Imports (DSEI) |
| 5/25/2018 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 237NO PMA | Division of Southeast Imports (DSEI) |
| 5/18/2018 | 87MOZACID, HYALURONIC, INTRAARTICULAR | Division of Southeast Imports (DSEI) | |
| 3/30/2018 | 87MOZACID, HYALURONIC, INTRAARTICULAR | Division of Southeast Imports (DSEI) | |
| 3/30/2018 | 87MOZACID, HYALURONIC, INTRAARTICULAR | Division of Southeast Imports (DSEI) | |
| 3/8/2018 | 79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE | 237NO PMA | Division of Southeast Imports (DSEI) |
| 9/5/2017 | 87MOZACID, HYALURONIC, INTRAARTICULAR | Division of Northern Border Imports (DNBI) | |
| 7/5/2017 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 3/22/2017 | 87MOZACID, HYALURONIC, INTRAARTICULAR | Division of Southeast Imports (DSEI) | |
| 3/14/2017 | 65QAZ02BOTOX | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Guangzhou Xiubo Medical Equipment Co. Ltd's FDA import refusal history?
Guangzhou Xiubo Medical Equipment Co. Ltd (FEI: 3010976338) has 15 FDA import refusal record(s) in our database, spanning from 3/14/2017 to 4/25/2023.
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. Guangzhou Xiubo Medical Equipment Co. Ltd's FEI number is 3010976338.
What types of violations has Guangzhou Xiubo Medical Equipment Co. Ltd received?
Guangzhou Xiubo Medical Equipment Co. Ltd has been cited for 11 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 Xiubo Medical Equipment Co. Ltd come from?
All FDA import refusal data for Guangzhou Xiubo Medical Equipment 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.