GOLD MINTS PRODUCTS CO. LTD.
⚠️ High Risk
FEI: 3007143344 • Bangkok • THAILAND
FEI Number
3007143344
Location
Bangkok
Country
THAILANDAddress
248/1 Soi Sopon Alongside Excpressway, Seeyak Bangna, Bangna, Bangkok, , 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
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).
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.
STD LABEL
The article appears to not bear labeling prescribed by the performance standard established under section 514.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
DANGEROUS
The article appears to be dangerous to health when used in the dosage or manner, or with the frequency or duration, prescribed, recommended, or suggested in the labeling thereof.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/28/2025 | 62MAQ08MENTHOL (ANTI-PRURITIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/28/2025 | 62MAQ08MENTHOL (ANTI-PRURITIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/28/2025 | 62MAY08MENTHOL (ANTI-PRURITIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/17/2021 | 62UAQ99ANTI-TUSSIVE/COLD N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/14/2020 | 66VDQ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 5/26/2017 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 5/26/2017 | 53DD02PERFUMES (FRAGRANCE PREPARATIONS) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 5/26/2017 | 53DD02PERFUMES (FRAGRANCE PREPARATIONS) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 8/4/2016 | 62MDQ08MENTHOL (ANTI-PRURITIC) | Division of West Coast Imports (DWCI) | |
| 8/4/2016 | 62MDQ99ANTI-PRURITIC N.E.C. | Division of West Coast Imports (DWCI) | |
| 9/30/2015 | 77KCOINHALER, NASAL | Cincinnati District Office (CIN-DO) | |
| 10/16/2012 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Minneapolis District Office (MIN-DO) |
| 5/25/2011 | 77KCOINHALER, NASAL | Los Angeles District Office (LOS-DO) | |
| 1/28/2010 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 11/18/2009 | 77KCOINHALER, NASAL | Los Angeles District Office (LOS-DO) | |
| 11/18/2009 | 77KCOINHALER, NASAL | Los Angeles District Office (LOS-DO) | |
| 3/5/2009 | 77KCOINHALER, NASAL | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is GOLD MINTS PRODUCTS CO. LTD.'s FDA import refusal history?
GOLD MINTS PRODUCTS CO. LTD. (FEI: 3007143344) has 17 FDA import refusal record(s) in our database, spanning from 3/5/2009 to 5/28/2025.
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. GOLD MINTS PRODUCTS CO. LTD.'s FEI number is 3007143344.
What types of violations has GOLD MINTS PRODUCTS CO. LTD. received?
GOLD MINTS PRODUCTS CO. LTD. has been cited for 7 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 GOLD MINTS PRODUCTS CO. LTD. come from?
All FDA import refusal data for GOLD MINTS PRODUCTS 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.