Guangzhou Panyu Wellunit Underwear Manufacturing Co Ltd.
⚠️ Moderate Risk
FEI: 3006002851 • Guangzhou, Guangdong • CHINA
FEI Number
3006002851
Location
Guangzhou, Guangdong
Country
CHINAAddress
3 Guoshi Road, Dong Cun Shi, Guangzhou, Guangdong, 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).
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/16/2014 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Los Angeles District Office (LOS-DO) | |
| 12/18/2006 | 24BCE99BEAN, CORN, PEA, DRIED OR PASTE, N.E.C. (VEGETABLE) | 83NO PROCESS | San Francisco District Office (SAN-DO) |
| 12/18/2006 | 24BCE99BEAN, CORN, PEA, DRIED OR PASTE, N.E.C. (VEGETABLE) | 83NO PROCESS | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Guangzhou Panyu Wellunit Underwear Manufacturing Co Ltd.'s FDA import refusal history?
Guangzhou Panyu Wellunit Underwear Manufacturing Co Ltd. (FEI: 3006002851) has 3 FDA import refusal record(s) in our database, spanning from 12/18/2006 to 1/16/2014.
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. Guangzhou Panyu Wellunit Underwear Manufacturing Co Ltd.'s FEI number is 3006002851.
What types of violations has Guangzhou Panyu Wellunit Underwear Manufacturing Co Ltd. received?
Guangzhou Panyu Wellunit Underwear Manufacturing 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 Guangzhou Panyu Wellunit Underwear Manufacturing Co Ltd. come from?
All FDA import refusal data for Guangzhou Panyu Wellunit Underwear Manufacturing 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.