Shenzhen Shenbao Huacheng Tech.Co.,Ltd.
⚠️ Moderate Risk
FEI: 2000028016 • Shenzhen, Guangdong • CHINA
FEI Number
2000028016
Location
Shenzhen, Guangdong
Country
CHINAAddress
Jinyuanlu, Heaocun; Henggang Jiedao Longgang District, Shenzhen, 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
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).
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 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.
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.
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 |
|---|---|---|---|
| 3/17/2015 | 68XYY20DEVICE/DIAG PROD FOR ANIMAL USED MORE THAN 1 SPECIES | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
| 11/12/2014 | 84HCCDEVICE, BIOFEEDBACK | New Orleans District Office (NOL-DO) | |
| 11/12/2014 | 84HCCDEVICE, BIOFEEDBACK | New Orleans District Office (NOL-DO) | |
| 11/12/2014 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | New Orleans District Office (NOL-DO) | |
| 1/15/2013 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Shenzhen Shenbao Huacheng Tech.Co.,Ltd.'s FDA import refusal history?
Shenzhen Shenbao Huacheng Tech.Co.,Ltd. (FEI: 2000028016) has 5 FDA import refusal record(s) in our database, spanning from 1/15/2013 to 3/17/2015.
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 Shenbao Huacheng Tech.Co.,Ltd.'s FEI number is 2000028016.
What types of violations has Shenzhen Shenbao Huacheng Tech.Co.,Ltd. received?
Shenzhen Shenbao Huacheng Tech.Co.,Ltd. has been cited for 6 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 Shenbao Huacheng Tech.Co.,Ltd. come from?
All FDA import refusal data for Shenzhen Shenbao Huacheng Tech.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.