Rohto-Mentholatum (Vietnam) Co., Ltd.
⚠️ High Risk
FEI: 3008808745 • Thuan An Town, Binh Duong Province • VIETNAM
FEI Number
3008808745
Location
Thuan An Town, Binh Duong Province
Country
VIETNAMAddress
16 Vsip, Street 5, Vietnam-Singapore Industrial Park, Binh Hoa Ward, Thuan An Town, Binh Duong Province, Vietnam
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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/20/2013 | 65LAK16HYDROXYPROPYL CELLULOSE (PROTECTANT) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 11/20/2013 | 60CBK51TETRAHYDROZOLINE HCL (ADRENERGIC) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 11/20/2013 | 60CBK46NAPHAZOLINE HCL (ADRENERGIC) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 11/20/2013 | 65LAK16HYDROXYPROPYL CELLULOSE (PROTECTANT) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 11/20/2013 | 60CBK51TETRAHYDROZOLINE HCL (ADRENERGIC) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 11/20/2013 | 60CBK51TETRAHYDROZOLINE HCL (ADRENERGIC) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 11/20/2013 | 65LAK16HYDROXYPROPYL CELLULOSE (PROTECTANT) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 11/20/2013 | 60CBK51TETRAHYDROZOLINE HCL (ADRENERGIC) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 11/20/2013 | 60CBK51TETRAHYDROZOLINE HCL (ADRENERGIC) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 11/20/2013 | 60CBK46NAPHAZOLINE HCL (ADRENERGIC) | 27DRUG GMPS | New York District Office (NYK-DO) |
| 11/20/2013 | 60CBK51TETRAHYDROZOLINE HCL (ADRENERGIC) | 27DRUG GMPS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Rohto-Mentholatum (Vietnam) Co., Ltd.'s FDA import refusal history?
Rohto-Mentholatum (Vietnam) Co., Ltd. (FEI: 3008808745) has 11 FDA import refusal record(s) in our database, spanning from 11/20/2013 to 11/20/2013.
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. Rohto-Mentholatum (Vietnam) Co., Ltd.'s FEI number is 3008808745.
What types of violations has Rohto-Mentholatum (Vietnam) Co., Ltd. received?
Rohto-Mentholatum (Vietnam) Co., Ltd. has been cited for 1 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 Rohto-Mentholatum (Vietnam) Co., Ltd. come from?
All FDA import refusal data for Rohto-Mentholatum (Vietnam) 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.