Aide Plastic Co., Ltd
⚠️ Moderate Risk
FEI: 3010688506 • Shijiazhuang, Hebei • CHINA
FEI Number
3010688506
Location
Shijiazhuang, Hebei
Country
CHINAAddress
No.88, Huai An West Rd., , Shijiazhuang, Hebei, 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
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
Refusal History
Frequently Asked Questions
What is Aide Plastic Co., Ltd's FDA import refusal history?
Aide Plastic Co., Ltd (FEI: 3010688506) has 1 FDA import refusal record(s) in our database, spanning from 9/15/2016 to 9/15/2016.
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. Aide Plastic Co., Ltd's FEI number is 3010688506.
What types of violations has Aide Plastic Co., Ltd received?
Aide Plastic 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 Aide Plastic Co., Ltd come from?
All FDA import refusal data for Aide Plastic 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.