Universal Weaver Corporation
⚠️ Moderate Risk
FEI: 3003775107 • Bataan, Taiwan • CHINA
FEI Number
3003775107
Location
Bataan, Taiwan
Country
CHINAAddress
7th Street Phase IIF, No. 167 FU, Batann Economic Zone, Mariveles, Bataan, Taiwan, China
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 |
|---|---|---|---|
| 8/28/2009 | 79FYBGOWN, PATIENT | Chicago District Office (CHI-DO) | |
| 8/28/2009 | 79FYBGOWN, PATIENT | Chicago District Office (CHI-DO) | |
| 8/28/2009 | 79FYBGOWN, PATIENT | Chicago District Office (CHI-DO) | |
| 8/28/2009 | 79FYBGOWN, PATIENT | Chicago District Office (CHI-DO) |
Frequently Asked Questions
What is Universal Weaver Corporation's FDA import refusal history?
Universal Weaver Corporation (FEI: 3003775107) has 4 FDA import refusal record(s) in our database, spanning from 8/28/2009 to 8/28/2009.
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. Universal Weaver Corporation's FEI number is 3003775107.
What types of violations has Universal Weaver Corporation received?
Universal Weaver Corporation 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 Universal Weaver Corporation come from?
All FDA import refusal data for Universal Weaver Corporation 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.