Beijing Polus Tech Co., Ltd.
⚠️ Moderate Risk
FEI: 3012061089 • Beijing, Beijing • CHINA
FEI Number
3012061089
Location
Beijing, Beijing
Country
CHINAAddress
Unit Room 801 3, 7 Blug 3, Beijing, Beijing, 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
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 |
|---|---|---|---|
| 9/22/2016 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 9/22/2016 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 9/22/2016 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 9/22/2016 | 63RBY04SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Beijing Polus Tech Co., Ltd.'s FDA import refusal history?
Beijing Polus Tech Co., Ltd. (FEI: 3012061089) has 4 FDA import refusal record(s) in our database, spanning from 9/22/2016 to 9/22/2016.
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. Beijing Polus Tech Co., Ltd.'s FEI number is 3012061089.
What types of violations has Beijing Polus Tech Co., Ltd. received?
Beijing Polus Tech 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 Beijing Polus Tech Co., Ltd. come from?
All FDA import refusal data for Beijing Polus Tech 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.