Thai Nippon Rubber Industry Co., Ltd.
⚠️ Moderate Risk
FEI: 3003514364 • Sriracha Chonburi • THAILAND
FEI Number
3003514364
Location
Sriracha Chonburi
Country
THAILANDAddress
49-49/1, Epz-1, Laemchabang, Industrial Estate, Sriracha Chonburi, , 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
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).
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.
HOLES
The quality of the article falls below that which it purports or is represented to possess, in that the devices contain defects/holes.
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 |
|---|---|---|---|
| 9/12/2018 | 85HISCONDOM | Division of West Coast Imports (DWCI) | |
| 9/12/2018 | 85LTZCONDOM WITH NONOXYNOL-9 | Division of West Coast Imports (DWCI) | |
| 8/15/2008 | 85HISCONDOM | 477HOLES | Seattle District Office (SEA-DO) |
| 4/28/2006 | 85HISCONDOM | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Thai Nippon Rubber Industry Co., Ltd.'s FDA import refusal history?
Thai Nippon Rubber Industry Co., Ltd. (FEI: 3003514364) has 4 FDA import refusal record(s) in our database, spanning from 4/28/2006 to 9/12/2018.
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. Thai Nippon Rubber Industry Co., Ltd.'s FEI number is 3003514364.
What types of violations has Thai Nippon Rubber Industry Co., Ltd. received?
Thai Nippon Rubber Industry 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 Thai Nippon Rubber Industry Co., Ltd. come from?
All FDA import refusal data for Thai Nippon Rubber Industry 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.