Tianjin Tianyao Pharmaceuticals Co., Ltd.
⚠️ Moderate Risk
FEI: 3008256667 • Tianjin Economic-Technological, Tianjin • CHINA
FEI Number
3008256667
Location
Tianjin Economic-Technological, Tianjin
Country
CHINAAddress
West Area, No. 19 Xinye 9th Street; Development Area, Tianjin Economic-Technological, 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
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
INSANITARY
The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/3/2021 | 64LCY37HYDROCORTISONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/21/2015 | 64LCT19DEXAMETHASONE (GLUCOCORTICOID) | 186INSANITARY | Southwest Import District Office (SWI-DO) |
| 12/21/2015 | 64LCT20DEXAMETHASONE SODIUM PHOSPHATE (GLUCOCORTICOID) | 186INSANITARY | Southwest Import District Office (SWI-DO) |
| 12/21/2015 | 64LCT56PREDNISONE (GLUCOCORTICOID) | 186INSANITARY | Southwest Import District Office (SWI-DO) |
| 9/14/2010 | 64LCA56PREDNISONE (GLUCOCORTICOID) | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 5/24/2006 | 64LCS56PREDNISONE (GLUCOCORTICOID) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 5/3/2005 | 64LAS38HYDROCORTISONE ACETATE (GLUCOCORTICOID) | New York District Office (NYK-DO) | |
| 3/28/2005 | 64LAS38HYDROCORTISONE ACETATE (GLUCOCORTICOID) | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Tianjin Tianyao Pharmaceuticals Co., Ltd.'s FDA import refusal history?
Tianjin Tianyao Pharmaceuticals Co., Ltd. (FEI: 3008256667) has 8 FDA import refusal record(s) in our database, spanning from 3/28/2005 to 11/3/2021.
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 Tianyao Pharmaceuticals Co., Ltd.'s FEI number is 3008256667.
What types of violations has Tianjin Tianyao Pharmaceuticals Co., Ltd. received?
Tianjin Tianyao Pharmaceuticals 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 Tianjin Tianyao Pharmaceuticals Co., Ltd. come from?
All FDA import refusal data for Tianjin Tianyao 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.