FDA 483 - UCSF Medical Center Clinical Laboratories Transfusion Service at Mission Bay - November 27, 2017

An FDA inspection of UCSF Medical Center Clinical Laboratories Transfusion Service at Mission Bay in San Francisco, CA, revealed significant issues with the timely reporting of biological product deviations. The facility failed to report multiple deviations within the required 45-calendar-day timeframe. Additionally, the firm did not adhere to its own written standard operating procedures for investigating and correcting product deviations, specifically regarding the reporting of errors to external agencies.