Tasly Pharmaceuticals Group Co. Ltd
⚠️ Moderate Risk
FEI: 3014188680 • Beichen District, Tianjin • CHINA
FEI Number
3014188680
Location
Beichen District, Tianjin
Country
CHINAAddress
No. 2 Puji Hedong Road Pufali, , Beichen District, 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).
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.
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
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 |
|---|---|---|---|
| 5/9/2023 | 54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | Division of West Coast Imports (DWCI) | |
| 9/2/2009 | 31KGT02TEA, GREEN | 482NUTRIT LBL | New Orleans District Office (NOL-DO) |
| 9/2/2009 | 64MCH01CLOMIPHENE CITRATE (GONAD-STIMULATING PRINCIPLE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Tasly Pharmaceuticals Group Co. Ltd's FDA import refusal history?
Tasly Pharmaceuticals Group Co. Ltd (FEI: 3014188680) has 3 FDA import refusal record(s) in our database, spanning from 9/2/2009 to 5/9/2023.
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. Tasly Pharmaceuticals Group Co. Ltd's FEI number is 3014188680.
What types of violations has Tasly Pharmaceuticals Group Co. Ltd received?
Tasly Pharmaceuticals Group 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 Tasly Pharmaceuticals Group Co. Ltd come from?
All FDA import refusal data for Tasly Pharmaceuticals Group 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.