FDA 483 - UCSF Medical Center Clinical Laboratories Transfusion Service at Mission Bay - November 27, 2017
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.
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.
- Inspection Date
- November 27, 2017
- Product Type
- Biologics
ID · eae30701-da30-4e19-b7b7-d03a41a2f4f0