Ou Mei Si Health Food (Shenzhen) Co. Ltd.
⚠️ Moderate Risk
FEI: 3008020767 • Shenzhen • CHINA
FEI Number
3008020767
Location
Shenzhen
Country
CHINAAddress
3f, Building A, Luowuwei Industrial, , Shenzhen, , 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).
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/28/2010 | 54ECY99HERBALS & BOTANICAL TEAS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 4/28/2010 | 54ECY99HERBALS & BOTANICAL TEAS, N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 4/28/2010 | 54ECY99HERBALS & BOTANICAL TEAS, N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Ou Mei Si Health Food (Shenzhen) Co. Ltd.'s FDA import refusal history?
Ou Mei Si Health Food (Shenzhen) Co. Ltd. (FEI: 3008020767) has 3 FDA import refusal record(s) in our database, spanning from 4/28/2010 to 4/28/2010.
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. Ou Mei Si Health Food (Shenzhen) Co. Ltd.'s FEI number is 3008020767.
What types of violations has Ou Mei Si Health Food (Shenzhen) Co. Ltd. received?
Ou Mei Si Health Food (Shenzhen) 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 Ou Mei Si Health Food (Shenzhen) Co. Ltd. come from?
All FDA import refusal data for Ou Mei Si Health Food (Shenzhen) 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.