JIANGSU ALFA GLOVE CO LTD
⚠️ Moderate Risk
FEI: 3007504660 • Suqian • CHINA
FEI Number
3007504660
Location
Suqian
Country
CHINAAddress
Room Flat 502, 10 Tianxing Garden, Suqian, , 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
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
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.
Refusal History
Frequently Asked Questions
What is JIANGSU ALFA GLOVE CO LTD's FDA import refusal history?
JIANGSU ALFA GLOVE CO LTD (FEI: 3007504660) has 3 FDA import refusal record(s) in our database, spanning from 4/30/2018 to 7/27/2018.
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. JIANGSU ALFA GLOVE CO LTD's FEI number is 3007504660.
What types of violations has JIANGSU ALFA GLOVE CO LTD received?
JIANGSU ALFA GLOVE 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 JIANGSU ALFA GLOVE CO LTD come from?
All FDA import refusal data for JIANGSU ALFA GLOVE 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.