SAS Rubber Products Co., Ltd.
⚠️ Moderate Risk
FEI: 1000381433 • Bangkok • THAILAND
FEI Number
1000381433
Location
Bangkok
Country
THAILANDAddress
20/3 Bangkok Bazar Road, Lumpinee, Prathumwan, Bangkok, , 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
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/4/2012 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | New Orleans District Office (NOL-DO) |
| 6/4/2012 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 477HOLES | New Orleans District Office (NOL-DO) |
| 5/24/2012 | 80LYYGLOVE, PATIENT EXAMINATION, LATEX | 126FAILS STD | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is SAS Rubber Products Co., Ltd.'s FDA import refusal history?
SAS Rubber Products Co., Ltd. (FEI: 1000381433) has 3 FDA import refusal record(s) in our database, spanning from 5/24/2012 to 6/4/2012.
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. SAS Rubber Products Co., Ltd.'s FEI number is 1000381433.
What types of violations has SAS Rubber Products Co., Ltd. received?
SAS Rubber Products 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 SAS Rubber Products Co., Ltd. come from?
All FDA import refusal data for SAS Rubber Products 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.