FDA 483 - Winter Haven Hospital, Inc. - February 21, 2019

Winter Haven Hospital, Inc. in Winter Haven, FL, was cited for multiple deficiencies related to blood donor management and reporting during an FDA inspection. The observations primarily concern failures in donor notification of test results, lookback procedures for HIV and HCV, and submission of biological product deviation reports. Additionally, issues were noted regarding donor physical examination protocols, informed consent for plateletpheresis, and obtaining donor contact information.