Aspiration Intl
⚠️ Moderate Risk
FEI: 3008045675 • Tsuen Wan, New Territories • HONG KONG
FEI Number
3008045675
Location
Tsuen Wan, New Territories
Country
HONG KONGAddress
Unit 2706, Mega Trade Centre; 1 Mei Wan St., 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
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).
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).
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.
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/16/2012 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | Cincinnati District Office (CIN-DO) | |
| 8/29/2012 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | Cincinnati District Office (CIN-DO) | |
| 4/1/2011 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Cincinnati District Office (CIN-DO) | |
| 4/1/2011 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Cincinnati District Office (CIN-DO) | |
| 4/1/2011 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Cincinnati District Office (CIN-DO) | |
| 3/31/2011 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | Cincinnati District Office (CIN-DO) | |
| 11/29/2010 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Cincinnati District Office (CIN-DO) | |
| 11/29/2010 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Cincinnati District Office (CIN-DO) | |
| 11/29/2010 | 86MVNLENS, CONTACT (DISPOSABLE) | Cincinnati District Office (CIN-DO) | |
| 11/29/2010 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Cincinnati District Office (CIN-DO) | |
| 11/29/2010 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Cincinnati District Office (CIN-DO) | |
| 1/15/2010 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Cincinnati District Office (CIN-DO) | |
| 1/15/2010 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Cincinnati District Office (CIN-DO) | |
| 1/15/2010 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Cincinnati District Office (CIN-DO) | |
| 1/15/2010 | 86HQDLENS, CONTACT (OTHER MATERIAL) - DAILY | Cincinnati District Office (CIN-DO) | |
| 1/15/2010 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Cincinnati District Office (CIN-DO) | |
| 1/15/2010 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Cincinnati District Office (CIN-DO) | |
| 1/15/2010 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Cincinnati District Office (CIN-DO) | |
| 1/15/2010 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Cincinnati District Office (CIN-DO) | |
| 1/15/2010 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Cincinnati District Office (CIN-DO) | |
| 1/15/2010 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Aspiration Intl's FDA import refusal history?
Aspiration Intl (FEI: 3008045675) has 21 FDA import refusal record(s) in our database, spanning from 1/15/2010 to 10/16/2012.
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. Aspiration Intl's FEI number is 3008045675.
What types of violations has Aspiration Intl received?
Aspiration Intl 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 Aspiration Intl come from?
All FDA import refusal data for Aspiration Intl 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.