One Form Co., Ltd.
⚠️ Moderate Risk
FEI: 3005452594 • Taipei, Taipei - Special Municipality • TAIWAN
FEI Number
3005452594
Location
Taipei, Taipei - Special Municipality
Country
TAIWANAddress
NO. 105, 9f-6, Cheng de Road Sec.1, Taipei, Taipei - Special Municipality, 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
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).
PESTICIDES
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be adulterated because it contains a pesticide chemical, which is in violation of section 402(a)(2)(B). Contains:
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/31/2008 | 54ECR99HERBALS & BOTANICAL TEAS, N.E.C. | 2920PESTICIDES | Los Angeles District Office (LOS-DO) |
| 3/7/2007 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 3/7/2007 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 3/7/2007 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 3/7/2007 | 79KGXTAPE AND BANDAGE, ADHESIVE | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is One Form Co., Ltd.'s FDA import refusal history?
One Form Co., Ltd. (FEI: 3005452594) has 5 FDA import refusal record(s) in our database, spanning from 3/7/2007 to 7/31/2008.
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. One Form Co., Ltd.'s FEI number is 3005452594.
What types of violations has One Form Co., Ltd. received?
One Form Co., Ltd. has been cited for 2 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 One Form Co., Ltd. come from?
All FDA import refusal data for One Form 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.