S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED
⚠️ High Risk
FEI: 3005979923 • Si Racha, Chonburi • THAILAND
FEI Number
3005979923
Location
Si Racha, Chonburi
Country
THAILANDAddress
789/159 Moo 1, Nong Kho-Laemchabang Road, , Si Racha, Chonburi, Thailand
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
POISONOUS
The article is subject to refusal of admission pursuant Section 801(a)(3) in that The cosmetic appears to bear or contain a poisonous or deleterious substance which may render it injurious to users under the conditions prescribed in the labeling thereof, or, under such conditions of use as are customary or usual.
HELD INSAN
The cosmetic appears to have been prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
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).
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).
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
COSMETFPLA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain an undeclared color additive which renders it misbranded within the meaning of Sections 1454(c)(3)(B) and 1456 of the Fair Packaging and Labeling Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/9/2024 | 66PBY16OCTOCRYLENE (ULTRAVIOLET SCREEN/SUNSCREEN) | Division of Southeast Imports (DSEI) | |
| 12/19/2023 | 53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Division of Northern Border Imports (DNBI) | |
| 3/31/2015 | 53DH03POWDERS (DUSTING AND TALCUM, EXCLUDING AFTERSHAVE TALC) (FRAGRANCE PREPARATIONS) | Division of Northeast Imports (DNEI) | |
| 9/21/2012 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | 310POISONOUS | Baltimore District Office (BLT-DO) |
| 6/5/2012 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | Atlanta District Office (ATL-DO) | |
| 4/23/2012 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | Baltimore District Office (BLT-DO) | |
| 4/23/2012 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | Baltimore District Office (BLT-DO) | |
| 4/16/2012 | 53CH03EYE SHADOW (EYE MAKEUP PREPARATIONS) | Baltimore District Office (BLT-DO) |
Frequently Asked Questions
What is S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED's FDA import refusal history?
S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED (FEI: 3005979923) has 8 FDA import refusal record(s) in our database, spanning from 4/16/2012 to 7/9/2024.
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. S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED's FEI number is 3005979923.
What types of violations has S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED received?
S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED 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 S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED come from?
All FDA import refusal data for S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED 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.