Guangzhou Shiruoni Cosmetics Co., Ltd
⚠️ Moderate Risk
FEI: 3014510437 • Guangzhou, Guangdong • CHINA
FEI Number
3014510437
Location
Guangzhou, Guangdong
Country
CHINAAddress
Bldg. 6 Room 307, 12 Dagang Road; West Zone, Guangzhou, 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
708NOREG
It has been determined the drug was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
TAMPERING
It appears that the packing does not conform with current good manufacturing practices under 21 CFR 211.132 for tamper-resistant packaging.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/23/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 3873708NOREG | Division of Northeast Imports (DNEI) |
| 2/23/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | 3873708NOREG | Division of Northeast Imports (DNEI) |
| 2/23/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Northeast Imports (DNEI) | |
| 2/19/2021 | 62FAL23ISOPROPYL ALCOHOL (ANTI-INFECTIVE, TOPICAL) | 223FALSE | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Guangzhou Shiruoni Cosmetics Co., Ltd's FDA import refusal history?
Guangzhou Shiruoni Cosmetics Co., Ltd (FEI: 3014510437) has 4 FDA import refusal record(s) in our database, spanning from 2/19/2021 to 2/23/2021.
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 Shiruoni Cosmetics Co., Ltd's FEI number is 3014510437.
What types of violations has Guangzhou Shiruoni Cosmetics Co., Ltd received?
Guangzhou Shiruoni Cosmetics 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 Shiruoni Cosmetics Co., Ltd come from?
All FDA import refusal data for Guangzhou Shiruoni Cosmetics 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.