SHENZHEN SAMSHINGZER TECHNOLOGY
⚠️ Moderate Risk
FEI: 3012859396 • Shenzhen • CHINA
FEI Number
3012859396
Location
Shenzhen
Country
CHINAAddress
Floor 2, Bldg C, Hongshengyuan Ind Park, No 339 Bulong Road Bantian Street Longgang District, 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
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
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.
TP FLAVOR
This article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that it is, or purports to be or is represented as, a tobacco product that is subject to a tobacco product standard established under section 907, and violates 907 (a) (1) (A) in that the article appears to contain, as a constituent or additive, an artificial or natural flavor (other than tobacco or menthol) or an herb or spice, that is a characterizing flavor of the tobacco product or tobacco smoke.
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/27/2020 | 98LCA01E-CIGARETTE | 3520TP FLAVOR | Division of Southeast Imports (DSEI) |
| 9/24/2020 | 98LCA01E-CIGARETTE | 3854TPLKUSSLLB | Division of Southeast Imports (DSEI) |
| 9/24/2020 | 98LCA01E-CIGARETTE | 3854TPLKUSSLLB | Division of Southeast Imports (DSEI) |
| 9/24/2020 | 98LCA01E-CIGARETTE | 3854TPLKUSSLLB | Division of Southeast Imports (DSEI) |
| 8/10/2020 | 98LAA01E-CIGARETTE | Division of Southeast Imports (DSEI) | |
| 12/4/2017 | 64XBJ99KERATOLYTIC N.E.C. | Division of Southeast Imports (DSEI) | |
| 10/10/2017 | 53IH01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | Division of Southeast Imports (DSEI) | |
| 10/10/2017 | 53IH01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | Division of Southeast Imports (DSEI) | |
| 10/10/2017 | 53IH01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | Division of Southeast Imports (DSEI) | |
| 10/10/2017 | 53IH99OTHER ORAL HYGIENE PRODUCTS, WITHOUT FLUORIDE, N.E.C. | Division of Southeast Imports (DSEI) | |
| 10/10/2017 | 53IH01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | Division of Southeast Imports (DSEI) | |
| 9/15/2017 | 53IH01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SHENZHEN SAMSHINGZER TECHNOLOGY's FDA import refusal history?
SHENZHEN SAMSHINGZER TECHNOLOGY (FEI: 3012859396) has 12 FDA import refusal record(s) in our database, spanning from 9/15/2017 to 10/27/2020.
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 3012859396.
What types of violations has SHENZHEN SAMSHINGZER TECHNOLOGY received?
SHENZHEN SAMSHINGZER TECHNOLOGY has been cited for 8 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.