Siam Moei Co., Ltd
⚠️ Moderate Risk
FEI: 3009543187 • Mae Sot, TAK • THAILAND
FEI Number
3009543187
Location
Mae Sot, TAK
Country
THAILANDAddress
522, 3-4 Intarakeeree Road.Maei Sot, Mae Sot, TAK, 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
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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 PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/7/2016 | 16AEE99FISH, N.E.C. | New York District Office (NYK-DO) | |
| 5/20/2014 | 16ACP99FISH, N.E.C. | 249FILTHY | New York District Office (NYK-DO) |
| 5/20/2014 | 16AGH99FISH, N.E.C. | 249FILTHY | New York District Office (NYK-DO) |
| 5/20/2014 | 62MBJ08MENTHOL (ANTI-PRURITIC) | New York District Office (NYK-DO) | |
| 6/21/2012 | 66YCY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 472NO ENGLISH | Division of Northeast Imports (DNEI) |
| 6/21/2012 | 62MDJ08MENTHOL (ANTI-PRURITIC) | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is Siam Moei Co., Ltd's FDA import refusal history?
Siam Moei Co., Ltd (FEI: 3009543187) has 6 FDA import refusal record(s) in our database, spanning from 6/21/2012 to 1/7/2016.
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. Siam Moei Co., Ltd's FEI number is 3009543187.
What types of violations has Siam Moei Co., Ltd received?
Siam Moei Co., Ltd has been cited for 8 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 Siam Moei Co., Ltd come from?
All FDA import refusal data for Siam Moei 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.