Bella Co. Ltd.
⚠️ Moderate Risk
FEI: 3004069985 • Taipei • TAIWAN
FEI Number
3004069985
Location
Taipei
Country
TAIWANAddress
1fl, No.105, Jinglong St. Wenshan, , Taipei, , 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).
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).
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/14/2012 | 53CY06MASCARA (EYE MAKEUP PREPARATIONS) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 11/4/2008 | 60QCO67LIDOCAINE (ANESTHETIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 7/10/2008 | 53CH07EYELASH AND EYEBROW DYE (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | New York District Office (NYK-DO) |
| 3/24/2008 | 60QBL67LIDOCAINE (ANESTHETIC) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 3/24/2008 | 60QBL67LIDOCAINE (ANESTHETIC) | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 12/11/2006 | 60QIK67LIDOCAINE (ANESTHETIC) | Southwest Import District Office (SWI-DO) | |
| 1/12/2004 | 53CY08EYE MAKEUP KITS (EYE MAKEUP PREPARATIONS) | 471CSTIC LBLG | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Bella Co. Ltd.'s FDA import refusal history?
Bella Co. Ltd. (FEI: 3004069985) has 7 FDA import refusal record(s) in our database, spanning from 1/12/2004 to 3/14/2012.
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. Bella Co. Ltd.'s FEI number is 3004069985.
What types of violations has Bella Co. Ltd. received?
Bella Co. Ltd. has been cited for 5 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 Bella Co. Ltd. come from?
All FDA import refusal data for Bella 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.