Moon Well
⚠️ Moderate Risk
FEI: 3009695667 • Jia Xing, Zhejiang • CHINA
FEI Number
3009695667
Location
Jia Xing, Zhejiang
Country
CHINAAddress
Bldg 10 Room 801, Tingjia Xing, Jia Xing, Zhejiang, 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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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 |
|---|---|---|---|
| 2/5/2013 | 85OCAEXERCISER, PELVIC FLOOR MUSCLE, BIRTH PREPARATION | Los Angeles District Office (LOS-DO) | |
| 2/5/2013 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Los Angeles District Office (LOS-DO) | |
| 2/5/2013 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Los Angeles District Office (LOS-DO) | |
| 2/5/2013 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Los Angeles District Office (LOS-DO) | |
| 2/5/2013 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Los Angeles District Office (LOS-DO) | |
| 2/5/2013 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Los Angeles District Office (LOS-DO) | |
| 2/5/2013 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Los Angeles District Office (LOS-DO) | |
| 2/5/2013 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Los Angeles District Office (LOS-DO) | |
| 2/5/2013 | 89LYGMASSAGER, THERAPEUTIC, MANUAL | Los Angeles District Office (LOS-DO) | |
| 2/5/2013 | 78LKYDEVICE, EXTERNAL PENILE RIGIDITY | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Moon Well's FDA import refusal history?
Moon Well (FEI: 3009695667) has 10 FDA import refusal record(s) in our database, spanning from 2/5/2013 to 2/5/2013.
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. Moon Well's FEI number is 3009695667.
What types of violations has Moon Well received?
Moon Well has been cited for 5 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 Moon Well come from?
All FDA import refusal data for Moon Well 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.