FDA 483 - Donor Services Laboratories Inc Tampa - September 12, 2025

An FDA inspection of Donor Services Laboratories Inc Tampa, a tissue testing laboratory, revealed significant deficiencies in record-keeping practices. Observations included a failure to concurrently document incubation times, inadequate investigation and documentation of failed test runs, and incomplete batch checklist forms lacking critical information such as personnel initials and timestamps. These issues indicate a lack of robust data integrity and quality program oversight.