FREIGHTACE INT CO LTD
⚠️ Moderate Risk
FEI: 3016651401 • Taipei City • TAIWAN
FEI Number
3016651401
Location
Taipei City
Country
TAIWANAddress
12f-2 No 102 Gangfus Rdtaipei City, , Taipei 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
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/3/2025 | 63VBY02HYDROQUINONE (DEPIGMENTOR) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 7/2/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Southeast Imports (DSEI) | |
| 6/15/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Southeast Imports (DSEI) | |
| 6/10/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Southeast Imports (DSEI) | |
| 6/5/2020 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Southeast Imports (DSEI) | |
| 5/28/2020 | 66VAH99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 5/28/2020 | 66VAH99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 5/28/2020 | 66VCH99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 5/28/2020 | 66VAH99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 5/28/2020 | 66VAH99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is FREIGHTACE INT CO LTD's FDA import refusal history?
FREIGHTACE INT CO LTD (FEI: 3016651401) has 10 FDA import refusal record(s) in our database, spanning from 5/28/2020 to 7/3/2025.
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. FREIGHTACE INT CO LTD's FEI number is 3016651401.
What types of violations has FREIGHTACE INT CO LTD received?
FREIGHTACE INT 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 FREIGHTACE INT CO LTD come from?
All FDA import refusal data for FREIGHTACE INT 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.