FDA 483 - Biomat USA Inc - March 14, 2019

During an inspection from March 12-14, 2019, Plasma Biological Services, LLC in Nashville, TN, was cited for failing to submit biological product deviation reports within the required 45-day timeframe. The firm submitted 42 such reports late between February 2017 and March 2019, indicating a systemic issue with timely reporting of deviations.