Hangzhou Facecare Cosmetics Co., Ltd.
⚠️ High Risk
FEI: 3008655176 • Hangzhou, Zhejiang • CHINA
FEI Number
3008655176
Location
Hangzhou, Zhejiang
Country
CHINAAddress
Xiashastreet, No. 88 Xiasha Road; Qiantang District, Hangzhou, Zhejiang, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
INSANITARY
The article is subject to refusal of admission pursuant to section 801(a)(3) in that the article appears to have been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/9/2018 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 5/9/2018 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 3/19/2018 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 12/18/2017 | 66PAL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 186INSANITARY | Division of West Coast Imports (DWCI) |
| 12/18/2017 | 66PAL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 186INSANITARY | Division of West Coast Imports (DWCI) |
| 12/18/2017 | 66PAL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 186INSANITARY | Division of West Coast Imports (DWCI) |
| 12/18/2017 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 186INSANITARY | Division of West Coast Imports (DWCI) |
| 12/18/2017 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Division of West Coast Imports (DWCI) |
| 12/18/2017 | 66PBL99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Hangzhou Facecare Cosmetics Co., Ltd.'s FDA import refusal history?
Hangzhou Facecare Cosmetics Co., Ltd. (FEI: 3008655176) has 9 FDA import refusal record(s) in our database, spanning from 12/18/2017 to 5/9/2018.
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. Hangzhou Facecare Cosmetics Co., Ltd.'s FEI number is 3008655176.
What types of violations has Hangzhou Facecare Cosmetics Co., Ltd. received?
Hangzhou Facecare Cosmetics 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 Hangzhou Facecare Cosmetics Co., Ltd. come from?
All FDA import refusal data for Hangzhou Facecare 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.