483
UCP Bioscience IncUCP Bioscience Inc – FDA 483, Nov 18, 2024
Record Details
UCF Bioscience Inc, a specification developer in Milpitas, CA, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included inadequate design history file documentation for a urine cup, failure to appoint a management representative for the quality system, and the absence of written medical device reporting procedures. These issues indicate a lack of robust quality control and regulatory compliance.
View Company Profile
ID · 63a8d743-a976-4beb-974c-9f0ed8284b71
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.