Able Touch Enterprise Co., Ltd.
⚠️ Moderate Risk
FEI: 3004784288 • Taipei • TAIWAN
FEI Number
3004784288
Location
Taipei
Country
TAIWANAddress
Rm. 701, No. 147, Sec. 2,Chien Kuo N., , Taipei, , 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
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).
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
LENS CERT
The lenses are declared by accompanying certificate to meet the requirements for impact-resistant lenses in 21 CFR 801.410 but does not appear to be impact-resistant.
Refusal History
Frequently Asked Questions
What is Able Touch Enterprise Co., Ltd.'s FDA import refusal history?
Able Touch Enterprise Co., Ltd. (FEI: 3004784288) has 2 FDA import refusal record(s) in our database, spanning from 3/28/2005 to 6/30/2005.
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. Able Touch Enterprise Co., Ltd.'s FEI number is 3004784288.
What types of violations has Able Touch Enterprise Co., Ltd. received?
Able Touch Enterprise Co., Ltd. has been cited for 3 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 Able Touch Enterprise Co., Ltd. come from?
All FDA import refusal data for Able Touch Enterprise 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.