GaleMed Xiamen Co., Ltd.
✅ Low Risk
FEI: 3006783791 • Xiamen, Fujian • CHINA
FEI Number
3006783791
Location
Xiamen, Fujian
Country
CHINAAddress
Amoy Export, 39 East Rd; Haicang, Xiamen, Fujian, China
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity violations.
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
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/13/2020 | 73BXJCLIP, NOSE | 3280FRNMFGREG | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is GaleMed Xiamen Co., Ltd.'s FDA import refusal history?
GaleMed Xiamen Co., Ltd. (FEI: 3006783791) has 1 FDA import refusal record(s) in our database, spanning from 10/13/2020 to 10/13/2020.
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. GaleMed Xiamen Co., Ltd.'s FEI number is 3006783791.
What types of violations has GaleMed Xiamen Co., Ltd. received?
GaleMed Xiamen 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 GaleMed Xiamen Co., Ltd. come from?
All FDA import refusal data for GaleMed Xiamen 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.