Bath Concepts Cosmetics (DongGuan) Co., Ltd.
⚠️ Moderate Risk
FEI: 3008080893 • Dongguan, Guangdong • CHINA
FEI Number
3008080893
Location
Dongguan, Guangdong
Country
CHINAAddress
No. 1 Nange 5th Road, Daojiao Town, Dongguan, 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).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/5/2023 | 60QBL99ANESTHETIC, N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 12/5/2023 | 60QBL99ANESTHETIC, N.E.C. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 11/4/2009 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 11/4/2009 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Bath Concepts Cosmetics (DongGuan) Co., Ltd.'s FDA import refusal history?
Bath Concepts Cosmetics (DongGuan) Co., Ltd. (FEI: 3008080893) has 4 FDA import refusal record(s) in our database, spanning from 11/4/2009 to 12/5/2023.
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. Bath Concepts Cosmetics (DongGuan) Co., Ltd.'s FEI number is 3008080893.
What types of violations has Bath Concepts Cosmetics (DongGuan) Co., Ltd. received?
Bath Concepts Cosmetics (DongGuan) Co., Ltd. has been cited for 3 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 Bath Concepts Cosmetics (DongGuan) Co., Ltd. come from?
All FDA import refusal data for Bath Concepts Cosmetics (DongGuan) 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.