Suretex, Ltd.
⚠️ High Risk
FEI: 3002808272 • Surat-Thani • THAILAND
FEI Number
3002808272
Location
Surat-Thani
Country
THAILANDAddress
31/1, Moo 4, Tambon Khao Hua Kwai, Phun Phin, Surat-Thani, , Thailand
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
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).
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 |
|---|---|---|---|
| 12/11/2025 | 85HISCONDOM | 477HOLES | Division of Northern Border Imports (DNBI) |
| 9/14/2015 | 85HISCONDOM | Chicago District Office (CHI-DO) | |
| 4/19/2010 | 85HISCONDOM | 477HOLES | Division of Southeast Imports (DSEI) |
| 7/2/2009 | 85HISCONDOM | 477HOLES | Atlanta District Office (ATL-DO) |
| 6/13/2008 | 85HISCONDOM | 477HOLES | Atlanta District Office (ATL-DO) |
| 1/24/2006 | 85HISCONDOM | 477HOLES | Florida District Office (FLA-DO) |
| 1/24/2006 | 85HISCONDOM | 477HOLES | Florida District Office (FLA-DO) |
| 1/24/2006 | 85HISCONDOM | 477HOLES | Florida District Office (FLA-DO) |
| 1/24/2006 | 85HISCONDOM | 477HOLES | Florida District Office (FLA-DO) |
| 10/14/2005 | 85LTZCONDOM WITH NONOXYNOL-9 | 477HOLES | Atlanta District Office (ATL-DO) |
| 8/19/2005 | 85LTZCONDOM WITH NONOXYNOL-9 | 477HOLES | Atlanta District Office (ATL-DO) |
| 4/16/2003 | 85HISCONDOM | 477HOLES | Atlanta District Office (ATL-DO) |
Frequently Asked Questions
What is Suretex, Ltd.'s FDA import refusal history?
Suretex, Ltd. (FEI: 3002808272) has 12 FDA import refusal record(s) in our database, spanning from 4/16/2003 to 12/11/2025.
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. Suretex, Ltd.'s FEI number is 3002808272.
What types of violations has Suretex, Ltd. received?
Suretex, 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 Suretex, Ltd. come from?
All FDA import refusal data for Suretex, 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.