SHENZHEN JUNOBEAUTY TECHNOLOGY C
⚠️ Moderate Risk
FEI: 3017777733 • Shenzhen • CHINA
FEI Number
3017777733
Location
Shenzhen
Country
CHINAAddress
No 512 Shajiing St, , 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
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.
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/26/2021 | 79OHTLIGHT BASED OVER-THE-COUNTER HAIR REMOVAL | Division of Southeast Imports (DSEI) | |
| 3/15/2021 | 79OHTLIGHT BASED OVER-THE-COUNTER HAIR REMOVAL | 237NO PMA | Division of Southeast Imports (DSEI) |
| 3/15/2021 | 79OHTLIGHT BASED OVER-THE-COUNTER HAIR REMOVAL | 237NO PMA | Division of Southeast Imports (DSEI) |
| 1/20/2021 | 79OHTLIGHT BASED OVER-THE-COUNTER HAIR REMOVAL | Division of Southeast Imports (DSEI) | |
| 1/14/2021 | 79OHTLIGHT BASED OVER-THE-COUNTER HAIR REMOVAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/14/2021 | 79OHTLIGHT BASED OVER-THE-COUNTER HAIR REMOVAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/14/2021 | 79OHTLIGHT BASED OVER-THE-COUNTER HAIR REMOVAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/14/2021 | 79OHTLIGHT BASED OVER-THE-COUNTER HAIR REMOVAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/14/2021 | 79OHTLIGHT BASED OVER-THE-COUNTER HAIR REMOVAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 1/8/2021 | 79OHTLIGHT BASED OVER-THE-COUNTER HAIR REMOVAL | Division of Southeast Imports (DSEI) | |
| 1/6/2021 | 79OHTLIGHT BASED OVER-THE-COUNTER HAIR REMOVAL | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is SHENZHEN JUNOBEAUTY TECHNOLOGY C's FDA import refusal history?
SHENZHEN JUNOBEAUTY TECHNOLOGY C (FEI: 3017777733) has 11 FDA import refusal record(s) in our database, spanning from 1/6/2021 to 4/26/2021.
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. SHENZHEN JUNOBEAUTY TECHNOLOGY C's FEI number is 3017777733.
What types of violations has SHENZHEN JUNOBEAUTY TECHNOLOGY C received?
SHENZHEN JUNOBEAUTY TECHNOLOGY C has been cited for 4 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 SHENZHEN JUNOBEAUTY TECHNOLOGY C come from?
All FDA import refusal data for SHENZHEN JUNOBEAUTY TECHNOLOGY C 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.