Benchmark Electronics (Thailand) Public Co., Ltd.
⚠️ Moderate Risk
FEI: 3003899230 • Bang Pa-In, Phra Nakhon Si Ayutthaya • THAILAND
FEI Number
3003899230
Location
Bang Pa-In, Phra Nakhon Si Ayutthaya
Country
THAILANDAddress
94 Moo 1, Hi-Tech Industrial Estate, Banlane, Bang-Pa, Bang Pa-In, Phra Nakhon Si Ayutthaya, 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
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).
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.
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).
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 |
|---|---|---|---|
| 5/27/2022 | 79ONGPOWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM\FRACTIONAL OUTPUT | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 5/27/2022 | 79ONGPOWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM\FRACTIONAL OUTPUT | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 5/26/2020 | 73PGJOXIMETER, WELLNESS | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/19/2019 | 79OLPOVER-THE-COUNTER POWERED RED/BLUE LIGHT BASED LASER FOR ACNE | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 2/19/2016 | 79GEXPOWERED LASER SURGICAL INSTRUMENTS | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 2/19/2016 | 79ONGPOWERED LASER SURGICAL INSTRUMENT WITH MICROBEAM\FRACTIONAL OUTPUT | 341REGISTERED | New Orleans District Office (NOL-DO) |
| 8/19/2013 | 75NBWSYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER | Division of Southeast Imports (DSEI) | |
| 3/4/2013 | 74DPSELECTROCARDIOGRAPH | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Benchmark Electronics (Thailand) Public Co., Ltd.'s FDA import refusal history?
Benchmark Electronics (Thailand) Public Co., Ltd. (FEI: 3003899230) has 8 FDA import refusal record(s) in our database, spanning from 3/4/2013 to 5/27/2022.
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. Benchmark Electronics (Thailand) Public Co., Ltd.'s FEI number is 3003899230.
What types of violations has Benchmark Electronics (Thailand) Public Co., Ltd. received?
Benchmark Electronics (Thailand) Public Co., Ltd. has been cited for 4 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 Benchmark Electronics (Thailand) Public Co., Ltd. come from?
All FDA import refusal data for Benchmark Electronics (Thailand) Public 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.