UCP Bioscience Inc
⚠️ Moderate Risk
FEI: 3004987297 • Milpitas, CA • UNITED STATES
FEI Number
3004987297
Location
Milpitas, CA
Country
UNITED STATESAddress
1900 Mccarthy Blvd Ste 204, , Milpitas, CA, United States
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
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
Frequently Asked Questions
What is UCP Bioscience Inc's FDA import refusal history?
UCP Bioscience Inc (FEI: 3004987297) has 1 FDA import refusal record(s) in our database, spanning from 5/26/2020 to 5/26/2020.
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. UCP Bioscience Inc's FEI number is 3004987297.
What types of violations has UCP Bioscience Inc received?
UCP Bioscience Inc 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 UCP Bioscience Inc come from?
All FDA import refusal data for UCP Bioscience Inc 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.