FDA 483 - Continental Services Group, Inc. - August 24, 2022

During an FDA inspection from August 16-24, 2022, of Continental Services Group, Inc., a blood bank and plasma center located at 2901 W Broward Blvd, Ft Lauderdale, FL, two observations were made. Cori D. Capik, CEO, was the individual to whom the report was issued.

Observation 1 noted a failure to maintain donor and general records. Specifically, the "Final Report for the Installation/Operational/Performance Qualification of the (b)(4) Software" dated May 1, 2022, did not identify the test cases used or the results of the testing for the validation of the (b)(4) Software, which was implemented on August 15, 2022, for documenting donor screening.

Observation 2 cited a failure to make reasonable attempts to notify donors within 8 weeks after determining they were deferred or ineligible for donation. From January 2020 to July 2022, the firm obtained (b)(4) donor reactive results for HIV and HCV. Four of these (b)(4) donors were not notified of their positive test results, including specific unit numbers with reactive results for HCV and HIV. The inspection was conducted by Investigators Sergio E Delgado, Laura E Garcia, and Annette Melendez.