Guilin Hwasun Pharmaceutical Co., Ltd.
⚠️ Moderate Risk
FEI: 3009030691 • Guilin, Guangxizhuangzuzizhiqu • CHINA
FEI Number
3009030691
Location
Guilin, Guangxizhuangzuzizhiqu
Country
CHINAAddress
89 Lingbei Rd, Lingchuanxian, Guilin, Guangxizhuangzuzizhiqu, 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
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 |
|---|---|---|---|
| 8/31/2012 | 62KOR10OMEPRAZOLE (ANTI-PERISTALTIC, ANTI-DIARRHEAL) | 72NEW VET DR | Philadelphia District Office (PHI-DO) |
Frequently Asked Questions
What is Guilin Hwasun Pharmaceutical Co., Ltd.'s FDA import refusal history?
Guilin Hwasun Pharmaceutical Co., Ltd. (FEI: 3009030691) has 1 FDA import refusal record(s) in our database, spanning from 8/31/2012 to 8/31/2012.
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. Guilin Hwasun Pharmaceutical Co., Ltd.'s FEI number is 3009030691.
What types of violations has Guilin Hwasun Pharmaceutical Co., Ltd. received?
Guilin Hwasun Pharmaceutical Co., Ltd. has been cited for 1 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 Guilin Hwasun Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for Guilin Hwasun 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.