Guangzhou Topwork Chemical Co., Ltd.
⚠️ Moderate Risk
FEI: 3008581787 • Guangzhou • CHINA
FEI Number
3008581787
Location
Guangzhou
Country
CHINAAddress
Building 1 Lidaocuiyuan Room 601, Lijiang Garden, Panyu, Guangzhou, , 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).
DRG REF EI
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article of drug appears to be adulterated under Section 501(j) because it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/6/2023 | 64LOY31FLUOROMETHOLONE (GLUCOCORTICOID) | 3845DRG REF EI | Division of Southeast Imports (DSEI) |
| 9/24/2021 | 62GIR21DIFLUPREDNATE (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/13/2009 | 63FAR99CARDIOTONIC N.E.C. | Southwest Import District Office (SWI-DO) | |
| 10/9/2007 | 60NCS04METHYLTESTOSTERONE (ANDROGEN) | 118NOT LISTED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Guangzhou Topwork Chemical Co., Ltd.'s FDA import refusal history?
Guangzhou Topwork Chemical Co., Ltd. (FEI: 3008581787) has 4 FDA import refusal record(s) in our database, spanning from 10/9/2007 to 3/6/2023.
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. Guangzhou Topwork Chemical Co., Ltd.'s FEI number is 3008581787.
What types of violations has Guangzhou Topwork Chemical Co., Ltd. received?
Guangzhou Topwork Chemical 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 Guangzhou Topwork Chemical Co., Ltd. come from?
All FDA import refusal data for Guangzhou Topwork Chemical 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.