Tianjin Hezhi Pharmaceutical Co., Ltd.
⚠️ Moderate Risk
FEI: 3008686977 • Tianjin, Tianjin • CHINA
FEI Number
3008686977
Location
Tianjin, Tianjin
Country
CHINAAddress
No. 22 Quanfa Road, Wuqing, Tianjin, 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
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
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 |
|---|---|---|---|
| 7/10/2014 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 7/10/2014 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 7/10/2014 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 7/10/2014 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) | |
| 7/10/2014 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Tianjin Hezhi Pharmaceutical Co., Ltd.'s FDA import refusal history?
Tianjin Hezhi Pharmaceutical Co., Ltd. (FEI: 3008686977) has 5 FDA import refusal record(s) in our database, spanning from 7/10/2014 to 7/10/2014.
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 Hezhi Pharmaceutical Co., Ltd.'s FEI number is 3008686977.
What types of violations has Tianjin Hezhi Pharmaceutical Co., Ltd. received?
Tianjin Hezhi Pharmaceutical 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 Hezhi Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for Tianjin Hezhi Pharmaceutical 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.