Valentine International Ltd.
⚠️ Moderate Risk
FEI: 3003245996 • Taipei Hsien • TAIWAN
FEI Number
3003245996
Location
Taipei Hsien
Country
TAIWANAddress
8fl, No.149, Sec.2, Ta Tung Rd., 221 Hsichih, Taipei Hsien, , 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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/7/2013 | 82JZRSUPPORT GELS | 118NOT LISTED | Florida District Office (FLA-DO) |
| 7/2/2012 | 89IMMFOOTREST, WHEELCHAIR | 341REGISTERED | Florida District Office (FLA-DO) |
| 7/2/2012 | 89KFTASSEMBLY, SHOULDER/ELBOW/FOREARM/WRIST/HAND, MECHANICAL | 341REGISTERED | Florida District Office (FLA-DO) |
| 3/17/2010 | 80LZBFINGER COT | 118NOT LISTED | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Valentine International Ltd.'s FDA import refusal history?
Valentine International Ltd. (FEI: 3003245996) has 4 FDA import refusal record(s) in our database, spanning from 3/17/2010 to 1/7/2013.
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. Valentine International Ltd.'s FEI number is 3003245996.
What types of violations has Valentine International Ltd. received?
Valentine International Ltd. has been cited for 2 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 Valentine International Ltd. come from?
All FDA import refusal data for Valentine International 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.