483
Winter Haven Hospital, Inc.Winter Haven Hospital, Inc. – FDA 483, Feb 21, 2019
Record Details
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.
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ID · f25a0884-5112-400b-b991-668ee8803b4f
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