Dongguang Shuoguo Silicone Products Co. Ltd.
⚠️ Moderate Risk
FEI: 3012901087 • Dongguan, Guangdong • CHINA
FEI Number
3012901087
Location
Dongguan, Guangdong
Country
CHINAAddress
Weiqian Road, Baishigang Village, Changping Town, Dongguan, 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
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).
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
NOCONTACT
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act because it appears to be a nonprescription drug that is misbranded within the meaning of Section 502(x) of the FD&C Act in that the product label fails to bear a domestic address or phone number through which the responsible person may receive a report of a serious adverse event with such drug.
N-RX INACT
The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.
Refusal History
Frequently Asked Questions
What is Dongguang Shuoguo Silicone Products Co. Ltd.'s FDA import refusal history?
Dongguang Shuoguo Silicone Products Co. Ltd. (FEI: 3012901087) has 2 FDA import refusal record(s) in our database, spanning from 1/5/2021 to 1/5/2021.
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. Dongguang Shuoguo Silicone Products Co. Ltd.'s FEI number is 3012901087.
What types of violations has Dongguang Shuoguo Silicone Products Co. Ltd. received?
Dongguang Shuoguo Silicone Products 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 Dongguang Shuoguo Silicone Products Co. Ltd. come from?
All FDA import refusal data for Dongguang Shuoguo Silicone Products 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.