Guangdong Medicines & Health Products
⚠️ Moderate Risk
FEI: 1000192906 • Guangzhouchina • CHINA
FEI Number
1000192906
Location
Guangzhouchina
Country
CHINAAddress
No. 10 Zhi Xin Road (South), , Guangzhouchina, , 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
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/13/2007 | 80KYPKIT, SUCTION, SNAKE-BITE | 118NOT LISTED | New York District Office (NYK-DO) |
| 4/29/2004 | 54FET99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 10/8/2002 | 25GCE99MIXED VEGETABLES, JUICE OR DRINK, N.E.C. | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 7/8/2002 | 30YCE99BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C. | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 7/8/2002 | 30YCE99BEVERAGE BASE NOT MENTIONED ELSEWHERE, N.E.C. | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Guangdong Medicines & Health Products's FDA import refusal history?
Guangdong Medicines & Health Products (FEI: 1000192906) has 5 FDA import refusal record(s) in our database, spanning from 7/8/2002 to 9/13/2007.
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. Guangdong Medicines & Health Products's FEI number is 1000192906.
What types of violations has Guangdong Medicines & Health Products received?
Guangdong Medicines & Health Products 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 Guangdong Medicines & Health Products come from?
All FDA import refusal data for Guangdong Medicines & Health Products 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.