Guangzhou Shentai Hygienic Products Co., Ltd
⚠️ Moderate Risk
FEI: 3016965521 • Guangzhou, Guangdong • CHINA
FEI Number
3016965521
Location
Guangzhou, Guangdong
Country
CHINAAddress
No. 2 Shiqing Road, Shijing Street, Baiyun District, Guangzhou, 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
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).
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
Frequently Asked Questions
What is Guangzhou Shentai Hygienic Products Co., Ltd's FDA import refusal history?
Guangzhou Shentai Hygienic Products Co., Ltd (FEI: 3016965521) has 1 FDA import refusal record(s) in our database, spanning from 9/29/2020 to 9/29/2020.
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. Guangzhou Shentai Hygienic Products Co., Ltd's FEI number is 3016965521.
What types of violations has Guangzhou Shentai Hygienic Products Co., Ltd received?
Guangzhou Shentai Hygienic Products Co., Ltd has been cited for 2 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 Shentai Hygienic Products Co., Ltd come from?
All FDA import refusal data for Guangzhou Shentai Hygienic 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.