Apex Well (Asia) Limited
⚠️ High Risk
FEI: 3003955782 • Kowloon • HONG KONG
FEI Number
3003955782
Location
Kowloon
Country
HONG KONGAddress
Flat A, 1/F, China Paint Building,, , Kowloon, , Hong Kong
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable 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
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
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).
LACKS N/C
The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
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 |
|---|---|---|---|
| 8/3/2005 | 62VBL99ANTI-VIRAL N.E.C. | San Francisco District Office (SAN-DO) | |
| 6/28/2004 | 29AEE99NONCARBONATED SOFT DRINK, N.E.C. | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 6/28/2004 | 29AEE99NONCARBONATED SOFT DRINK, N.E.C. | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 6/28/2004 | 29ACE99NONCARBONATED SOFT DRINK, N.E.C. | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 6/28/2004 | 29ACE99NONCARBONATED SOFT DRINK, N.E.C. | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 6/28/2004 | 29ACE99NONCARBONATED SOFT DRINK, N.E.C. | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 5/19/2004 | 29AEE99NONCARBONATED SOFT DRINK, N.E.C. | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 5/19/2004 | 29ACE99NONCARBONATED SOFT DRINK, N.E.C. | 83NO PROCESS | Los Angeles District Office (LOS-DO) |
| 5/12/2004 | 29ACT99NONCARBONATED SOFT DRINK, N.E.C. | San Francisco District Office (SAN-DO) | |
| 5/12/2004 | 29ACT99NONCARBONATED SOFT DRINK, N.E.C. | San Francisco District Office (SAN-DO) | |
| 5/12/2004 | 29ACT99NONCARBONATED SOFT DRINK, N.E.C. | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is Apex Well (Asia) Limited's FDA import refusal history?
Apex Well (Asia) Limited (FEI: 3003955782) has 11 FDA import refusal record(s) in our database, spanning from 5/12/2004 to 8/3/2005.
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. Apex Well (Asia) Limited's FEI number is 3003955782.
What types of violations has Apex Well (Asia) Limited received?
Apex Well (Asia) Limited has been cited for 6 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 Apex Well (Asia) Limited come from?
All FDA import refusal data for Apex Well (Asia) 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.