Qingdao Kangyuan Pharmaceutical Co. Ltd.
⚠️ Moderate Risk
FEI: 3006512854 • Qingdao, Shandong • CHINA
FEI Number
3006512854
Location
Qingdao, Shandong
Country
CHINAAddress
Yinghai Industrial Park, Jiaozhou City, Qingdao, Shandong, 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
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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.
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
Refusal History
Frequently Asked Questions
What is Qingdao Kangyuan Pharmaceutical Co. Ltd.'s FDA import refusal history?
Qingdao Kangyuan Pharmaceutical Co. Ltd. (FEI: 3006512854) has 2 FDA import refusal record(s) in our database, spanning from 3/25/2011 to 5/25/2011.
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. Qingdao Kangyuan Pharmaceutical Co. Ltd.'s FEI number is 3006512854.
What types of violations has Qingdao Kangyuan Pharmaceutical Co. Ltd. received?
Qingdao Kangyuan Pharmaceutical 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 Qingdao Kangyuan Pharmaceutical Co. Ltd. come from?
All FDA import refusal data for Qingdao Kangyuan Pharmaceutical 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.