Ace Tec Hk Co Limited
✅ Low Risk
FEI: 3008564673 • Kowloon • HONG KONG
FEI Number
3008564673
Location
Kowloon
Country
HONG KONGAddress
582-592 Nathan Road, , Kowloon, , Hong Kong
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/23/2016 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Ace Tec Hk Co Limited's FDA import refusal history?
Ace Tec Hk Co Limited (FEI: 3008564673) has 1 FDA import refusal record(s) in our database, spanning from 2/23/2016 to 2/23/2016.
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. Ace Tec Hk Co Limited's FEI number is 3008564673.
What types of violations has Ace Tec Hk Co Limited received?
Ace Tec Hk Co Limited 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 Ace Tec Hk Co Limited come from?
All FDA import refusal data for Ace Tec Hk Co Limited 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.