Team Precision Co., Ltd
⚠️ Moderate Risk
FEI: 3004582233 • Muang Prachin Buri, Prachin Buri • THAILAND
FEI Number
3004582233
Location
Muang Prachin Buri, Prachin Buri
Country
THAILANDAddress
Moo 13, 198 Suwansorn Rd,Dong Khee Lek, Muang Prachin Buri, Prachin Buri, Thailand
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
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/14/2009 | 79FTCLIGHT, ULTRAVIOLET, DERMATOLOGICAL | 508NO 510(K) | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Team Precision Co., Ltd's FDA import refusal history?
Team Precision Co., Ltd (FEI: 3004582233) has 1 FDA import refusal record(s) in our database, spanning from 12/14/2009 to 12/14/2009.
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. Team Precision Co., Ltd's FEI number is 3004582233.
What types of violations has Team Precision Co., Ltd received?
Team Precision 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 Team Precision Co., Ltd come from?
All FDA import refusal data for Team Precision 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.