Tianjin Kingyork Pharmaceuticals Co., Ltd
⚠️ Moderate Risk
FEI: 3013844768 • Tianjin Economic Tech, Tianjin • CHINA
FEI Number
3013844768
Location
Tianjin Economic Tech, Tianjin
Country
CHINAAddress
221 Huanghai Road, Development Area, Tianjin Economic Tech, Tianjin, 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
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).
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 |
|---|---|---|---|
| 11/12/2021 | 64LCJ28FLUOCINONIDE (GLUCOCORTICOID) | Division of Northern Border Imports (DNBI) | |
| 10/9/2020 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/11/2020 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 8/11/2020 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Tianjin Kingyork Pharmaceuticals Co., Ltd's FDA import refusal history?
Tianjin Kingyork Pharmaceuticals Co., Ltd (FEI: 3013844768) has 4 FDA import refusal record(s) in our database, spanning from 8/11/2020 to 11/12/2021.
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. Tianjin Kingyork Pharmaceuticals Co., Ltd's FEI number is 3013844768.
What types of violations has Tianjin Kingyork Pharmaceuticals Co., Ltd received?
Tianjin Kingyork Pharmaceuticals Co., Ltd has been cited for 2 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 Tianjin Kingyork Pharmaceuticals Co., Ltd come from?
All FDA import refusal data for Tianjin Kingyork Pharmaceuticals 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.