483
Biomat USA IncFDA 483 - Biomat USA Inc - July 27, 2018
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.
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ID · 24a4b27d-13be-461d-8e84-a5510dc531c6