Nanchang Dental Bright Technolog
⚠️ Moderate Risk
FEI: 3010457958 • Nanchang • CHINA
FEI Number
3010457958
Location
Nanchang
Country
CHINAAddress
No. 96 Jingdong Town Qingshanhu, , Nanchang, , 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).
COSMETLBLG
It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.
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.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/22/2016 | 53ID01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 475COSMETLBLG | Cincinnati District Office (CIN-DO) |
| 2/22/2016 | 53IY01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 475COSMETLBLG | Cincinnati District Office (CIN-DO) |
| 2/11/2016 | 53IY01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 471CSTIC LBLG | Cincinnati District Office (CIN-DO) |
| 4/23/2014 | 76EJKLINER, CAVITY, CALCIUM HYDROXIDE | Los Angeles District Office (LOS-DO) | |
| 4/23/2014 | 53IY99OTHER ORAL HYGIENE PRODUCTS, WITHOUT FLUORIDE, N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 4/23/2014 | 53IY99OTHER ORAL HYGIENE PRODUCTS, WITHOUT FLUORIDE, N.E.C. | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Nanchang Dental Bright Technolog's FDA import refusal history?
Nanchang Dental Bright Technolog (FEI: 3010457958) has 6 FDA import refusal record(s) in our database, spanning from 4/23/2014 to 2/22/2016.
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. Nanchang Dental Bright Technolog's FEI number is 3010457958.
What types of violations has Nanchang Dental Bright Technolog received?
Nanchang Dental Bright Technolog 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 Nanchang Dental Bright Technolog come from?
All FDA import refusal data for Nanchang Dental Bright Technolog 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.