Jiangxi Dentalbright Technology Co., Ltd
⚠️ Moderate Risk
FEI: 3012041047 • Jiujiang, Jiangxi • CHINA
FEI Number
3012041047
Location
Jiujiang, Jiangxi
Country
CHINAAddress
Makou Industrial park, , Yongxiu, Jiujiang, Jiangxi, 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
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.
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.
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).
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).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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 |
|---|---|---|---|
| 10/3/2024 | 76EHMSTRIP, POLISHING AGENT | Division of West Coast Imports (DWCI) | |
| 1/26/2024 | 76MAUERASER, DENTAL STAIN | Division of Southeast Imports (DSEI) | |
| 12/7/2022 | 76MAUERASER, DENTAL STAIN | 336INCONSPICU | Division of Southeast Imports (DSEI) |
| 7/15/2022 | 76MAUERASER, DENTAL STAIN | Division of Southeast Imports (DSEI) | |
| 11/20/2020 | 76MAUERASER, DENTAL STAIN | Division of Southeast Imports (DSEI) | |
| 6/8/2018 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 10/3/2017 | 53IH01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 471CSTIC LBLG | Division of Northern Border Imports (DNBI) |
| 10/3/2017 | 53IH01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 471CSTIC LBLG | Division of Northern Border Imports (DNBI) |
| 10/3/2017 | 53IH01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 471CSTIC LBLG | Division of Northern Border Imports (DNBI) |
| 10/3/2017 | 53IH01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 471CSTIC LBLG | Division of Northern Border Imports (DNBI) |
| 2/22/2016 | 53IY01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 471CSTIC LBLG | Cincinnati District Office (CIN-DO) |
| 2/10/2016 | 53ID01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | 471CSTIC LBLG | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Jiangxi Dentalbright Technology Co., Ltd's FDA import refusal history?
Jiangxi Dentalbright Technology Co., Ltd (FEI: 3012041047) has 12 FDA import refusal record(s) in our database, spanning from 2/10/2016 to 10/3/2024.
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. Jiangxi Dentalbright Technology Co., Ltd's FEI number is 3012041047.
What types of violations has Jiangxi Dentalbright Technology Co., Ltd received?
Jiangxi Dentalbright Technology Co., Ltd has been cited for 7 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 Jiangxi Dentalbright Technology Co., Ltd come from?
All FDA import refusal data for Jiangxi Dentalbright Technology 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.