Sinochem Tianjin Co., Ltd.
⚠️ Moderate Risk
FEI: 1000356896 • 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.
UNSFDIETSP
The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/22/2007 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 2120UNSFDIETSP | Los Angeles District Office (LOS-DO) |
| 7/28/2005 | 64LAZ56PREDNISONE (GLUCOCORTICOID) | San Francisco District Office (SAN-DO) | |
| 9/1/2004 | 64HAR05POTASSIUM GUAIACOLSULFONATE (EXPECTORANT) | 118NOT LISTED | New York District Office (NYK-DO) |
| 7/31/2004 | 64HAR05POTASSIUM GUAIACOLSULFONATE (EXPECTORANT) | 118NOT LISTED | New York District Office (NYK-DO) |
| 2/27/2002 | 64LCR37HYDROCORTISONE (GLUCOCORTICOID) | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Sinochem Tianjin Co., Ltd.'s FDA import refusal history?
Sinochem Tianjin Co., Ltd. (FEI: 1000356896) has 5 FDA import refusal record(s) in our database, spanning from 2/27/2002 to 8/22/2007.
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. Sinochem Tianjin Co., Ltd.'s FEI number is 1000356896.
What types of violations has Sinochem Tianjin Co., Ltd. received?
Sinochem Tianjin 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 Sinochem Tianjin Co., Ltd. come from?
All FDA import refusal data for Sinochem Tianjin 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.