Taiwan Three Mast Pharmaceutical Co., Ltd.
⚠️ Moderate Risk
FEI: 3004054758 • Tainan City • TAIWAN
FEI Number
3004054758
Location
Tainan City
Country
TAIWANAddress
211 Yongkehuan Rd., Yongkang Dist., Tainan City, , Taiwan
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
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).
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/6/2017 | 62MBD08MENTHOL (ANTI-PRURITIC) | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 9/6/2017 | 62MBD08MENTHOL (ANTI-PRURITIC) | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 9/6/2017 | 62MBD08MENTHOL (ANTI-PRURITIC) | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 6/29/2012 | 53LC01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Los Angeles District Office (LOS-DO) |
| 6/29/2012 | 79KGXTAPE AND BANDAGE, ADHESIVE | 27DRUG GMPS | Los Angeles District Office (LOS-DO) |
| 9/27/2011 | 62GBY99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 3/2/2009 | 62MBY08MENTHOL (ANTI-PRURITIC) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 3/2/2009 | 62MBL08MENTHOL (ANTI-PRURITIC) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 3/2/2009 | 62MBL08MENTHOL (ANTI-PRURITIC) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 12/1/2006 | 79KGXTAPE AND BANDAGE, ADHESIVE | Los Angeles District Office (LOS-DO) | |
| 12/1/2006 | 62GBJ99ANTI-INFLAMMATORY N.E.C. | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Taiwan Three Mast Pharmaceutical Co., Ltd.'s FDA import refusal history?
Taiwan Three Mast Pharmaceutical Co., Ltd. (FEI: 3004054758) has 11 FDA import refusal record(s) in our database, spanning from 12/1/2006 to 9/6/2017.
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. Taiwan Three Mast Pharmaceutical Co., Ltd.'s FEI number is 3004054758.
What types of violations has Taiwan Three Mast Pharmaceutical Co., Ltd. received?
Taiwan Three Mast 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 Taiwan Three Mast Pharmaceutical Co., Ltd. come from?
All FDA import refusal data for Taiwan Three Mast 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.