Shenzhen 91Ballpen Stationery Co., Ltd.
⚠️ Moderate Risk
FEI: 3007849398 • Wanfeng Ind. • CHINA
FEI Number
3007849398
Location
Wanfeng Ind.
Country
CHINAAddress
Bldg 17 F/3, 3 Zone; Shenzhen Baoan Dist. Shajing Town, Wanfeng Ind., , 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
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
NO TAG
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product to which is not affixed a certification in the form of a label or tag in conformity with section 534(h).
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
Refusal History
Frequently Asked Questions
What is Shenzhen 91Ballpen Stationery Co., Ltd.'s FDA import refusal history?
Shenzhen 91Ballpen Stationery Co., Ltd. (FEI: 3007849398) has 1 FDA import refusal record(s) in our database, spanning from 10/20/2009 to 10/20/2009.
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. Shenzhen 91Ballpen Stationery Co., Ltd.'s FEI number is 3007849398.
What types of violations has Shenzhen 91Ballpen Stationery Co., Ltd. received?
Shenzhen 91Ballpen Stationery Co., Ltd. has been cited for 3 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 Shenzhen 91Ballpen Stationery Co., Ltd. come from?
All FDA import refusal data for Shenzhen 91Ballpen Stationery 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.