Shenzhen Baojun Plastic Product Co.,Ltd
⚠️ Moderate Risk
FEI: 3012983342 • Shenzhen, Guangdong • CHINA
FEI Number
3012983342
Location
Shenzhen, Guangdong
Country
CHINAAddress
A Building 101, Luotian Community, Yanluo Street; Baoan, Shenzhen, Guangdong, 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
NO TAG
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product to which is not affixed a certification in the form of a label or tag in conformity with section 534(h).
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.
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).
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.
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).
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 |
|---|---|---|---|
| 11/8/2021 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/7/2020 | 95RERALIGNMENT LASER PRODUCT, SURVEYING LEVELING, ALIGNMENT LASER PRODUCTS | 278NO TAG | Division of Southwest Imports (DSWI) |
| 1/7/2020 | 95RERALIGNMENT LASER PRODUCT, SURVEYING LEVELING, ALIGNMENT LASER PRODUCTS | 278NO TAG | Division of Southwest Imports (DSWI) |
| 1/7/2020 | 95RERALIGNMENT LASER PRODUCT, SURVEYING LEVELING, ALIGNMENT LASER PRODUCTS | 278NO TAG | Division of Southwest Imports (DSWI) |
| 11/8/2019 | 84NUHSTIMULATOR, NERVE, TRANSCUTANEOUS, OVER-THE-COUNTER | Division of Southeast Imports (DSEI) | |
| 9/30/2019 | 95RERALIGNMENT LASER PRODUCT, SURVEYING LEVELING, ALIGNMENT LASER PRODUCTS | 278NO TAG | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is Shenzhen Baojun Plastic Product Co.,Ltd's FDA import refusal history?
Shenzhen Baojun Plastic Product Co.,Ltd (FEI: 3012983342) has 6 FDA import refusal record(s) in our database, spanning from 9/30/2019 to 11/8/2021.
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 Baojun Plastic Product Co.,Ltd's FEI number is 3012983342.
What types of violations has Shenzhen Baojun Plastic Product Co.,Ltd received?
Shenzhen Baojun Plastic Product Co.,Ltd has been cited for 7 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 Baojun Plastic Product Co.,Ltd come from?
All FDA import refusal data for Shenzhen Baojun Plastic Product 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.