Flying International (Macao) Ltd
⚠️ Moderate Risk
FEI: 3007001300 • Macaumacau • MACAU
FEI Number
3007001300
Location
Macaumacau
Country
MACAUAddress
Edif Comercial I Tak 19 Andar Brua, , Macaumacau, , Macau
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).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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).
FAILS STD
The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/20/2009 | 66BAS44NICOTINE DELIVERY SYSTEM | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 8/17/2009 | 66BAS44NICOTINE DELIVERY SYSTEM | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 1/15/2009 | 66BAY44NICOTINE DELIVERY SYSTEM | Cincinnati District Office (CIN-DO) | |
| 1/15/2009 | 66BIY44NICOTINE DELIVERY SYSTEM | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 11/5/2008 | 89ILJBATH, HYDRO-MASSAGE | Cincinnati District Office (CIN-DO) | |
| 11/5/2008 | 89ILJBATH, HYDRO-MASSAGE | Cincinnati District Office (CIN-DO) | |
| 10/3/2008 | 89ILJBATH, HYDRO-MASSAGE | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Flying International (Macao) Ltd's FDA import refusal history?
Flying International (Macao) Ltd (FEI: 3007001300) has 7 FDA import refusal record(s) in our database, spanning from 10/3/2008 to 8/20/2009.
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. Flying International (Macao) Ltd's FEI number is 3007001300.
What types of violations has Flying International (Macao) Ltd received?
Flying International (Macao) Ltd has been cited for 4 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 Flying International (Macao) Ltd come from?
All FDA import refusal data for Flying International (Macao) 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.