Tian Di Ren Medical Science And Technology Co Ltd
⚠️ Moderate Risk
FEI: 3007856441 • Harbin • CHINA
FEI Number
3007856441
Location
Harbin
Country
CHINAAddress
Diwang Bldg 30 Ganshui Rd Nangang, , Harbin, , 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).
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).
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
Refusal History
Frequently Asked Questions
What is Tian Di Ren Medical Science And Technology Co Ltd's FDA import refusal history?
Tian Di Ren Medical Science And Technology Co Ltd (FEI: 3007856441) has 2 FDA import refusal record(s) in our database, spanning from 12/3/2009 to 12/3/2009.
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. Tian Di Ren Medical Science And Technology Co Ltd's FEI number is 3007856441.
What types of violations has Tian Di Ren Medical Science And Technology Co Ltd received?
Tian Di Ren Medical Science And Technology 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 Tian Di Ren Medical Science And Technology Co Ltd come from?
All FDA import refusal data for Tian Di Ren Medical Science And Technology 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.