DONGGUAN BAO KANG DIAN ZI KE JI LIMITED
⚠️ Moderate Risk
FEI: 3004139561 • Dongguan, Guangdong • CHINA
FEI Number
3004139561
Location
Dongguan, Guangdong
Country
CHINAAddress
Yin Yang Industrial Estate, Zhangmutou;, Dongguan, 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
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
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.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
Frequently Asked Questions
What is DONGGUAN BAO KANG DIAN ZI KE JI LIMITED's FDA import refusal history?
DONGGUAN BAO KANG DIAN ZI KE JI LIMITED (FEI: 3004139561) has 2 FDA import refusal record(s) in our database, spanning from 12/13/2011 to 12/13/2011.
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. DONGGUAN BAO KANG DIAN ZI KE JI LIMITED's FEI number is 3004139561.
What types of violations has DONGGUAN BAO KANG DIAN ZI KE JI LIMITED received?
DONGGUAN BAO KANG DIAN ZI KE JI LIMITED has been cited for 4 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 DONGGUAN BAO KANG DIAN ZI KE JI LIMITED come from?
All FDA import refusal data for DONGGUAN BAO KANG DIAN ZI KE JI LIMITED 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.