Siam Yoko Co.,Ltd
⚠️ Moderate Risk
FEI: 2000016397 • Samutprakarn, Samut Prakan • THAILAND
FEI Number
2000016397
Location
Samutprakarn, Samut Prakan
Country
THAILANDAddress
340 Thepharak Rd., Thepharak, Moung, , Samutprakarn, Samut Prakan, 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
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
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).
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
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.
LACKS FIRM
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/26/2019 | 53JY04FEMININE DEODORANTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Division of Northern Border Imports (DNBI) | |
| 9/26/2019 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Division of Northern Border Imports (DNBI) | |
| 3/16/2017 | 52AJY50TEA KETTLE (FOODWARE, COOKWARE & TABLEWARE) | 320LACKS FIRM | New Orleans District Office (NOL-DO) |
| 3/16/2017 | 52AYY24MIXED SETS/SERVICE SETS (NOTE: USE SUBCLASS J, L, N, OR P ONLY) FOODWARE, COOKWARE & TABLEWARE | 320LACKS FIRM | New Orleans District Office (NOL-DO) |
| 8/4/2016 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of West Coast Imports (DWCI) | |
| 3/16/2016 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 12/11/2015 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 12/11/2015 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 10/13/2015 | 66VAL99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 8/18/2015 | 53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 471CSTIC LBLG | Cincinnati District Office (CIN-DO) |
| 5/12/2014 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Cincinnati District Office (CIN-DO) | |
| 11/15/2013 | 63VBY99DEPIGMENTOR N.E.C. | Cincinnati District Office (CIN-DO) | |
| 6/21/2013 | 53ED06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | New Orleans District Office (NOL-DO) | |
| 10/26/2012 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 7/31/2012 | 53FD01HAIR DYES AND COLORS (ALL TYPES REQUIRE CAUTION STATEMENTS AND PATCH TESTS) (HAIR COLORING PREPARATI | 471CSTIC LBLG | New Orleans District Office (NOL-DO) |
| 7/27/2012 | 62HAY99ANTI-MICROBIAL N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/29/2010 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Los Angeles District Office (LOS-DO) | |
| 11/29/2010 | 53GC03FOUNDATIONS (MAKEUP PREPARATIONS, NOT FOR EYES) | Los Angeles District Office (LOS-DO) | |
| 3/11/2010 | 53JK01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | Seattle District Office (SEA-DO) | |
| 12/2/2008 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Seattle District Office (SEA-DO) | |
| 12/2/2008 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Seattle District Office (SEA-DO) | |
| 12/2/2008 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Seattle District Office (SEA-DO) | |
| 12/2/2008 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Seattle District Office (SEA-DO) | |
| 10/6/2008 | 53BY01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 6/10/2008 | 53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Siam Yoko Co.,Ltd's FDA import refusal history?
Siam Yoko Co.,Ltd (FEI: 2000016397) has 25 FDA import refusal record(s) in our database, spanning from 6/10/2008 to 9/26/2019.
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 Yoko Co.,Ltd's FEI number is 2000016397.
What types of violations has Siam Yoko Co.,Ltd received?
Siam Yoko Co.,Ltd has been cited for 10 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 Yoko Co.,Ltd come from?
All FDA import refusal data for Siam Yoko 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.