Cabin Plastic Co., Ltd
⚠️ Moderate Risk
FEI: 3011107970 • Shijiazhuang, Hebei • CHINA
FEI Number
3011107970
Location
Shijiazhuang, Hebei
Country
CHINAAddress
No. 66 Hongqi St., , 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
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
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 Cabin Plastic Co., Ltd's FDA import refusal history?
Cabin Plastic Co., Ltd (FEI: 3011107970) has 1 FDA import refusal record(s) in our database, spanning from 10/16/2017 to 10/16/2017.
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. Cabin Plastic Co., Ltd's FEI number is 3011107970.
What types of violations has Cabin Plastic Co., Ltd received?
Cabin 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 Cabin Plastic Co., Ltd come from?
All FDA import refusal data for Cabin 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.