Golden Cup Pharmaceutical Co., Ltd
⚠️ Moderate Risk
FEI: 3011835803 • Bang Yai, Nonthaburi • THAILAND
FEI Number
3011835803
Location
Bang Yai, Nonthaburi
Country
THAILANDAddress
28/9 Moo 4, Bangmaenang, , Bang Yai, Nonthaburi, 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
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).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/12/2021 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northern Border Imports (DNBI) | |
| 4/2/2021 | 60LAO99ANALGESIC, N.E.C. | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 8/4/2016 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of West Coast Imports (DWCI) | |
| 6/16/2016 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) | |
| 6/16/2016 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Golden Cup Pharmaceutical Co., Ltd's FDA import refusal history?
Golden Cup Pharmaceutical Co., Ltd (FEI: 3011835803) has 5 FDA import refusal record(s) in our database, spanning from 6/16/2016 to 11/12/2021.
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. Golden Cup Pharmaceutical Co., Ltd's FEI number is 3011835803.
What types of violations has Golden Cup Pharmaceutical Co., Ltd received?
Golden Cup Pharmaceutical Co., Ltd has been cited for 4 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 Golden Cup Pharmaceutical Co., Ltd come from?
All FDA import refusal data for Golden Cup Pharmaceutical 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.