SHANDONG HAIDIKE MEDICAL PRODUCT CO., LTD.
⚠️ Moderate Risk
FEI: 3016655687 • Heze, Shandong • CHINA
FEI Number
3016655687
Location
Heze, Shandong
Country
CHINAAddress
Tianfu Rd Dongcheng, District, Shan County, Heze, 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
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).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
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 SHANDONG HAIDIKE MEDICAL PRODUCT CO., LTD.'s FDA import refusal history?
SHANDONG HAIDIKE MEDICAL PRODUCT CO., LTD. (FEI: 3016655687) has 1 FDA import refusal record(s) in our database, spanning from 8/12/2020 to 8/12/2020.
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. SHANDONG HAIDIKE MEDICAL PRODUCT CO., LTD.'s FEI number is 3016655687.
What types of violations has SHANDONG HAIDIKE MEDICAL PRODUCT CO., LTD. received?
SHANDONG HAIDIKE MEDICAL PRODUCT CO., LTD. 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 SHANDONG HAIDIKE MEDICAL PRODUCT CO., LTD. come from?
All FDA import refusal data for SHANDONG HAIDIKE MEDICAL PRODUCT 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.