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

Source: https://www.globalkeysolutions.net/records/483/winter-haven-hospital-inc/f25a0884-5112-400b-b991-668ee8803b4f

> FDA 483 for Winter Haven Hospital, Inc. on February 21, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Winter Haven Hospital, Inc.
- Inspection Date: 2019-02-21
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: 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.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/samantha-j-pinizzotto/296e8763-39e9-4b6d-9b89-661322d5a53c)

Company: https://www.globalkeysolutions.net/companies/winter-haven-hospital-inc/d058468e-d777-4807-89c6-c483249d3f0c

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6