Tp4 International Co Ltd
⚠️ Moderate Risk
FEI: 3006728240 • Din Daeng, Bangkok • THAILAND
FEI Number
3006728240
Location
Din Daeng, Bangkok
Country
THAILANDAddress
670-374 Soi Keanpatatana Asoke-Deindaeng, , Din Daeng, 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
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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 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.
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 ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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.
LIST INGRE
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(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/4/2016 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of West Coast Imports (DWCI) | |
| 8/4/2016 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of West Coast Imports (DWCI) | |
| 8/4/2016 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of West Coast Imports (DWCI) | |
| 8/4/2016 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of West Coast Imports (DWCI) | |
| 6/19/2015 | 53EY06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | Cincinnati District Office (CIN-DO) | |
| 3/26/2009 | 53JI04FEMININE DEODORANTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 471CSTIC LBLG | Los Angeles District Office (LOS-DO) |
| 3/26/2009 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | Los Angeles District Office (LOS-DO) | |
| 3/26/2009 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 3/26/2009 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 3/26/2009 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Tp4 International Co Ltd's FDA import refusal history?
Tp4 International Co Ltd (FEI: 3006728240) has 10 FDA import refusal record(s) in our database, spanning from 3/26/2009 to 8/4/2016.
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. Tp4 International Co Ltd's FEI number is 3006728240.
What types of violations has Tp4 International Co Ltd received?
Tp4 International 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 Tp4 International Co Ltd come from?
All FDA import refusal data for Tp4 International 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.