Apa Enterprise Ltd.
⚠️ Moderate Risk
FEI: 3005651100 • Tsuen Wan, New Territories • HONG KONG
FEI Number
3005651100
Location
Tsuen Wan, New Territories
Country
HONG KONGAddress
Rm 2101, Mega Trade Centre; 1-6 Mei Wan Street, Tsuen Wan, New Territories, Hong Kong
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
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/25/2007 | 89IMEPACK, HOT OR COLD, REUSEABLE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 7/25/2007 | 89IMEPACK, HOT OR COLD, REUSEABLE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 7/25/2007 | 89IMEPACK, HOT OR COLD, REUSEABLE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 7/25/2007 | 89IMEPACK, HOT OR COLD, REUSEABLE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 7/25/2007 | 89IMEPACK, HOT OR COLD, REUSEABLE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 7/25/2007 | 89IMEPACK, HOT OR COLD, REUSEABLE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 7/25/2007 | 89IMEPACK, HOT OR COLD, REUSEABLE | 341REGISTERED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Apa Enterprise Ltd.'s FDA import refusal history?
Apa Enterprise Ltd. (FEI: 3005651100) has 7 FDA import refusal record(s) in our database, spanning from 7/25/2007 to 7/25/2007.
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. Apa Enterprise Ltd.'s FEI number is 3005651100.
What types of violations has Apa Enterprise Ltd. received?
Apa Enterprise Ltd. 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 Apa Enterprise Ltd. come from?
All FDA import refusal data for Apa Enterprise 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.