Tianjin Jinjin Pharmaceutical Co. Ltd.
⚠️ Moderate Risk
FEI: 3003316563 • Xiqing Economic, Tianjin • CHINA
FEI Number
3003316563
Location
Xiqing Economic, Tianjin
Country
CHINAAddress
No. 8 Jingfu Road, Zone Of Zhangjiawo Industrial Dev. Zone, Xiqing Economic, 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).
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).
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/8/2019 | 64LAS37HYDROCORTISONE (GLUCOCORTICOID) | Division of Southeast Imports (DSEI) | |
| 3/29/2018 | 64LQR37HYDROCORTISONE (GLUCOCORTICOID) | Division of Southeast Imports (DSEI) | |
| 3/18/2016 | 64LAS37HYDROCORTISONE (GLUCOCORTICOID) | 186INSANITARY | Southwest Import District Office (SWI-DO) |
| 2/9/2005 | 64LAJ37HYDROCORTISONE (GLUCOCORTICOID) | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Tianjin Jinjin Pharmaceutical Co. Ltd.'s FDA import refusal history?
Tianjin Jinjin Pharmaceutical Co. Ltd. (FEI: 3003316563) has 4 FDA import refusal record(s) in our database, spanning from 2/9/2005 to 8/8/2019.
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 Jinjin Pharmaceutical Co. Ltd.'s FEI number is 3003316563.
What types of violations has Tianjin Jinjin Pharmaceutical Co. Ltd. received?
Tianjin Jinjin Pharmaceutical Co. Ltd. has been cited for 6 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 Jinjin Pharmaceutical Co. Ltd. come from?
All FDA import refusal data for Tianjin Jinjin 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.