Hangzhou Glamcos Biotech Co., Ltd.
⚠️ Moderate Risk
FEI: 3017053743 • Hangzhou, Zhejiang • CHINA
FEI Number
3017053743
Location
Hangzhou, Zhejiang
Country
CHINAAddress
No 288 Xiufeng Road Tonglu County, , Hangzhou, Zhejiang, 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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/31/2024 | 55QY41BENZALKONIUM CHLORIDE (PHARMACEUTIC NECESSITY - PRESERVATIVE) | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Hangzhou Glamcos Biotech Co., Ltd.'s FDA import refusal history?
Hangzhou Glamcos Biotech Co., Ltd. (FEI: 3017053743) has 1 FDA import refusal record(s) in our database, spanning from 12/31/2024 to 12/31/2024.
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. Hangzhou Glamcos Biotech Co., Ltd.'s FEI number is 3017053743.
What types of violations has Hangzhou Glamcos Biotech Co., Ltd. received?
Hangzhou Glamcos Biotech Co., Ltd. has been cited for 1 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 Glamcos Biotech Co., Ltd. come from?
All FDA import refusal data for Hangzhou Glamcos Biotech 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.