Infus Medical (Thailand) Co., Ltd.
⚠️ Moderate Risk
FEI: 1000434163 • Preaksa, Samutprakarn • THAILAND
FEI Number
1000434163
Location
Preaksa, Samutprakarn
Country
THAILANDAddress
706 Moo 4, Bangpoo Industrial Estate, I-Ea-T-Free Zone, Preaksa, Samutprakarn, 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
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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).
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/14/2022 | 87HRXARTHROSCOPE AND ACCESSORIES | Division of Southeast Imports (DSEI) | |
| 12/14/2022 | 87HRXARTHROSCOPE AND ACCESSORIES | Division of Southeast Imports (DSEI) | |
| 12/14/2022 | 87HRXARTHROSCOPE AND ACCESSORIES | Division of Southeast Imports (DSEI) | |
| 6/19/2013 | 85HIFINSUFFLATOR, LAPAROSCOPIC | Chicago District Office (CHI-DO) | |
| 9/14/2011 | 78KNWINSTRUMENT, BIOPSY | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 9/14/2011 | 78KNWINSTRUMENT, BIOPSY | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Infus Medical (Thailand) Co., Ltd.'s FDA import refusal history?
Infus Medical (Thailand) Co., Ltd. (FEI: 1000434163) has 6 FDA import refusal record(s) in our database, spanning from 9/14/2011 to 12/14/2022.
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. Infus Medical (Thailand) Co., Ltd.'s FEI number is 1000434163.
What types of violations has Infus Medical (Thailand) Co., Ltd. received?
Infus Medical (Thailand) 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 Infus Medical (Thailand) Co., Ltd. come from?
All FDA import refusal data for Infus Medical (Thailand) 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.