GUANGZHOU AOFU DAILY CHEMICAL CO., LTD
⚠️ Moderate Risk
FEI: 3018159735 • Guangzhou City • CHINA
FEI Number
3018159735
Location
Guangzhou City
Country
CHINAAddress
Add: One Of No. 188, Dashandi Road, Guilin Village, , Guangzhou City, , 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
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
NOCONTACT
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act because it appears to be a nonprescription drug that is misbranded within the meaning of Section 502(x) of the FD&C Act in that the product label fails to bear a domestic address or phone number through which the responsible person may receive a report of a serious adverse event with such drug.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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 |
|---|---|---|---|
| 5/11/2021 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Division of Southeast Imports (DSEI) | |
| 5/11/2021 | 53IY01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is GUANGZHOU AOFU DAILY CHEMICAL CO., LTD's FDA import refusal history?
GUANGZHOU AOFU DAILY CHEMICAL CO., LTD (FEI: 3018159735) has 2 FDA import refusal record(s) in our database, spanning from 5/11/2021 to 5/11/2021.
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. GUANGZHOU AOFU DAILY CHEMICAL CO., LTD's FEI number is 3018159735.
What types of violations has GUANGZHOU AOFU DAILY CHEMICAL CO., LTD received?
GUANGZHOU AOFU DAILY CHEMICAL CO., LTD 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 GUANGZHOU AOFU DAILY CHEMICAL CO., LTD come from?
All FDA import refusal data for GUANGZHOU AOFU DAILY CHEMICAL 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.