Bonasse Enterprises Co., Ltd.
⚠️ Moderate Risk
FEI: 1000375210 • Chungli City, Taoyuan County • TAIWAN
FEI Number
1000375210
Location
Chungli City, Taoyuan County
Country
TAIWANAddress
Chungli Industrial Park, No. 11-1 Song Chiang South Rd., Chungli City, Taoyuan County, Taiwan
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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.
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/17/2015 | 86LRXCASE, CONTACT LENS | Cincinnati District Office (CIN-DO) | |
| 12/17/2015 | 86LRXCASE, CONTACT LENS | Cincinnati District Office (CIN-DO) | |
| 12/17/2015 | 86LRXCASE, CONTACT LENS | Cincinnati District Office (CIN-DO) | |
| 4/10/2012 | 95RFTLASER PRINTER, UTILITY/PERIPHERAL LASER | 476NO REGISTR | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Bonasse Enterprises Co., Ltd.'s FDA import refusal history?
Bonasse Enterprises Co., Ltd. (FEI: 1000375210) has 4 FDA import refusal record(s) in our database, spanning from 4/10/2012 to 12/17/2015.
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. Bonasse Enterprises Co., Ltd.'s FEI number is 1000375210.
What types of violations has Bonasse Enterprises Co., Ltd. received?
Bonasse Enterprises Co., 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 Bonasse Enterprises Co., Ltd. come from?
All FDA import refusal data for Bonasse Enterprises Co., 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.