Communications Authority Of Th
⚠️ Moderate Risk
FEI: 3004017129 • Bangkok • THAILAND
FEI Number
3004017129
Location
Bangkok
Country
THAILANDAddress
99 Chaeng Matthana Road, , 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
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).
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.
NOT IMPACT
The article appears to not have impact-resistant lenses in accordance with 21 CFR 801.410.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/5/2005 | 77ESDHEARING-AID, AIR-CONDUCTION | Cincinnati District Office (CIN-DO) | |
| 10/2/2003 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Cincinnati District Office (CIN-DO) | |
| 10/2/2003 | 86HQGLENS, SPECTACLE, NON-CUSTOM (PRESCRIPTION) | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Communications Authority Of Th's FDA import refusal history?
Communications Authority Of Th (FEI: 3004017129) has 3 FDA import refusal record(s) in our database, spanning from 10/2/2003 to 4/5/2005.
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. Communications Authority Of Th's FEI number is 3004017129.
What types of violations has Communications Authority Of Th received?
Communications Authority Of Th 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 Communications Authority Of Th come from?
All FDA import refusal data for Communications Authority Of Th 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.