FDA 483 - Biomat USA Inc - July 27, 2018

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.