FDA 483 - Genesiscare - February 25, 2020

21st Century Oncology, Inc. in Naples, FL, a blood irradiation establishment, received a Form 483 with two observations. The inspection revealed significant issues with recordkeeping for blood and blood component irradiation processes, including undocumented verification steps and recurrent deficiencies in log entries. Additionally, the firm failed to consistently follow its own written standard operating procedures for blood irradiation documentation.