SHENZHEN SAMSHINGZER TECHNOLOGY
⚠️ Moderate Risk
FEI: 3013971240 • Shenzhen • CHINA
FEI Number
3013971240
Location
Shenzhen
Country
CHINAAddress
Floor 2, Bldg C Hongshen, Shenzhen, , 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
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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).
TPLKUSSLLB
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act because it is a tobacco product in package form that appears to be misbranded under section 903(a)(2)(D) of the FD&C Act in that the label does not provide the statement "sale only allowed in the United States" and the tobacco product is not subject to any exemptions or variations.
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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.
TPLACKFIRM
This article is subject to refusal of admission pursuant to section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it is a tobacco product in package form that appears to be misbranded under section 903(a)(2)(A) of the FD&C Act in that the label does not contain the name and place of business of the tobacco product 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.
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.
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).
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/4/2021 | 98LAA01E-CIGARETTE | 3854TPLKUSSLLB | Division of Southeast Imports (DSEI) |
| 9/8/2020 | 98LCA11VAPE PEN | Division of Southeast Imports (DSEI) | |
| 7/27/2020 | 98LAA01E-CIGARETTE | Division of Southeast Imports (DSEI) | |
| 6/19/2018 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
| 5/1/2018 | 78MRESOLUTION, SODIUM HYALURONATE | Division of Southeast Imports (DSEI) | |
| 5/1/2018 | 76JEQTOOTHBRUSH, POWERED | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 5/1/2018 | 53ED07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING) | Division of Southeast Imports (DSEI) | |
| 4/30/2018 | 66VBL99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 3/21/2018 | 77LWFDIALATOR, NASAL | Division of Southeast Imports (DSEI) | |
| 3/13/2018 | 53CD14EYELASH AND EYEBROW TREATMENTS-GEL, OIL, PRIMER, CONDITIONERS, SERUM, FORTIFIERS (EYE MAKEUP PREPARA | 473LABELING | Division of Southeast Imports (DSEI) |
| 2/16/2018 | 79ORECRYOGENIC, SKIN TAG REMOVAL, OTC | Division of Southeast Imports (DSEI) | |
| 1/24/2018 | 66VDL99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SHENZHEN SAMSHINGZER TECHNOLOGY's FDA import refusal history?
SHENZHEN SAMSHINGZER TECHNOLOGY (FEI: 3013971240) has 12 FDA import refusal record(s) in our database, spanning from 1/24/2018 to 2/4/2021.
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. SHENZHEN SAMSHINGZER TECHNOLOGY's FEI number is 3013971240.
What types of violations has SHENZHEN SAMSHINGZER TECHNOLOGY received?
SHENZHEN SAMSHINGZER TECHNOLOGY has been cited for 13 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 SHENZHEN SAMSHINGZER TECHNOLOGY come from?
All FDA import refusal data for SHENZHEN SAMSHINGZER TECHNOLOGY 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.