Guang Yang Medical Manufactory
⚠️ Moderate Risk
FEI: 3004841855 • Chai Wan • HONG KONG
FEI Number
3004841855
Location
Chai Wan
Country
HONG KONGAddress
Flat/Rmc 7/F Sunview Ind. Bldg 3 On Yip, , Chai Wan, , Hong Kong
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
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).
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/20/2005 | 54FCT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Los Angeles District Office (LOS-DO) | |
| 4/20/2005 | 66VBA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 4/20/2005 | 66VBA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 4/20/2005 | 66VBA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 4/20/2005 | 54FCT99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 11UNSAFE COL | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Guang Yang Medical Manufactory's FDA import refusal history?
Guang Yang Medical Manufactory (FEI: 3004841855) has 5 FDA import refusal record(s) in our database, spanning from 4/20/2005 to 4/20/2005.
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. Guang Yang Medical Manufactory's FEI number is 3004841855.
What types of violations has Guang Yang Medical Manufactory received?
Guang Yang Medical Manufactory 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 Guang Yang Medical Manufactory come from?
All FDA import refusal data for Guang Yang Medical Manufactory 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.