Asymchem Life Science (Tianjin) Co., Ltd.
⚠️ Moderate Risk
FEI: 3007060980 • Tianjin, Tianjin • CHINA
FEI Number
3007060980
Location
Tianjin, Tianjin
Country
CHINAAddress
No 71 7th Avenue, Teda, 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
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.
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).
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/15/2022 | 55RY99PHARMACEUTIC NECESSITIES, N.E.C. | 2280DIRSEXMPT | Division of Northeast Imports (DNEI) |
| 8/17/2022 | 62IIS99ANTI-NEOPLASTIC N.E.C. | Division of Northern Border Imports (DNBI) | |
| 1/17/2014 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | New Orleans District Office (NOL-DO) |
| 7/30/2012 | 66YIY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Asymchem Life Science (Tianjin) Co., Ltd.'s FDA import refusal history?
Asymchem Life Science (Tianjin) Co., Ltd. (FEI: 3007060980) has 4 FDA import refusal record(s) in our database, spanning from 7/30/2012 to 12/15/2022.
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. Asymchem Life Science (Tianjin) Co., Ltd.'s FEI number is 3007060980.
What types of violations has Asymchem Life Science (Tianjin) Co., Ltd. received?
Asymchem Life Science (Tianjin) 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 Asymchem Life Science (Tianjin) Co., Ltd. come from?
All FDA import refusal data for Asymchem Life Science (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.