483
Biomat USA IncFDA 483 - Biomat USA Inc - July 27, 2018
Discuss this record with AI
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.
Record Details
An FDA inspection of Grifols Reseda, a plasma center in Reseda, CA, from July 25-27, 2018, identified a significant failure to comply with reporting requirements. The firm repeatedly failed to submit biological product deviation reports (BPDRs) to CBER within the mandated 45-day period. This included critical delays in reporting cases involving donors who tested positive for Hepatitis B and C, as well as issues related to donor eligibility.
Open in Dashboard
ID · 24a4b27d-13be-461d-8e84-a5510dc531c6