Loongtotem Science And Technology Co., Ltd.
⚠️ Moderate Risk
FEI: 3007474573 • Guangdong • CHINA
FEI Number
3007474573
Location
Guangdong
Country
CHINAAddress
2f Pingan Bldg Gangkou Road 1, , 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
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).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/10/2009 | 66BAS44NICOTINE DELIVERY SYSTEM | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/24/2009 | 66BBY44NICOTINE DELIVERY SYSTEM | Seattle District Office (SEA-DO) | |
| 3/24/2009 | 66BBY44NICOTINE DELIVERY SYSTEM | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Loongtotem Science And Technology Co., Ltd.'s FDA import refusal history?
Loongtotem Science And Technology Co., Ltd. (FEI: 3007474573) has 3 FDA import refusal record(s) in our database, spanning from 3/24/2009 to 4/10/2009.
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. Loongtotem Science And Technology Co., Ltd.'s FEI number is 3007474573.
What types of violations has Loongtotem Science And Technology Co., Ltd. received?
Loongtotem Science And Technology Co., Ltd. has been cited for 2 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 Loongtotem Science And Technology Co., Ltd. come from?
All FDA import refusal data for Loongtotem Science And Technology 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.