Harbin Tian Di Ren Medical Science & Technology Co
⚠️ Moderate Risk
FEI: 3007697738 • Haerbin, Heilongjiang • CHINA
FEI Number
3007697738
Location
Haerbin, Heilongjiang
Country
CHINAAddress
Diwang Building Room 1706, NO. 30 Ganshuilu; Nangang, Haerbin, Heilongjiang, 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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/13/2010 | 89MLXPAD, MEDICATED, ADHESIVE, NON-ELECTRIC | Los Angeles District Office (LOS-DO) | |
| 1/13/2010 | 89MLXPAD, MEDICATED, ADHESIVE, NON-ELECTRIC | Los Angeles District Office (LOS-DO) | |
| 1/13/2010 | 89MLXPAD, MEDICATED, ADHESIVE, NON-ELECTRIC | Los Angeles District Office (LOS-DO) | |
| 1/13/2010 | 89MLXPAD, MEDICATED, ADHESIVE, NON-ELECTRIC | Los Angeles District Office (LOS-DO) | |
| 1/13/2010 | 89MLXPAD, MEDICATED, ADHESIVE, NON-ELECTRIC | Los Angeles District Office (LOS-DO) | |
| 1/13/2010 | 89MLXPAD, MEDICATED, ADHESIVE, NON-ELECTRIC | Los Angeles District Office (LOS-DO) | |
| 1/13/2010 | 89MLXPAD, MEDICATED, ADHESIVE, NON-ELECTRIC | Los Angeles District Office (LOS-DO) | |
| 8/10/2009 | 66YAY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Harbin Tian Di Ren Medical Science & Technology Co's FDA import refusal history?
Harbin Tian Di Ren Medical Science & Technology Co (FEI: 3007697738) has 8 FDA import refusal record(s) in our database, spanning from 8/10/2009 to 1/13/2010.
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. Harbin Tian Di Ren Medical Science & Technology Co's FEI number is 3007697738.
What types of violations has Harbin Tian Di Ren Medical Science & Technology Co received?
Harbin Tian Di Ren Medical Science & Technology Co 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 Harbin Tian Di Ren Medical Science & Technology Co come from?
All FDA import refusal data for Harbin Tian Di Ren Medical Science & Technology Co 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.