# FDA 483 - OneBlood, Inc. - April 02, 2019

Source: https://www.globalkeysolutions.net/records/483/oneblood-inc/7b60135d-d28b-4d93-b721-fbce3cef3872

> FDA 483 for OneBlood, Inc. on April 02, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: OneBlood, Inc.
- Inspection Date: 2019-04-02
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: OneBlood, Inc. in Fort Lauderdale, FL, a blood establishment computer software manufacturer, received eight observations during an FDA inspection. The firm was cited for significant deficiencies across its quality system, including inadequate design controls, corrective and preventive actions, medical device reporting, and complaint handling. These issues led to problems such as unresolved duplicate donor records, software failures, and untimely reporting of adverse events.

## Related Officers

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Company: https://www.globalkeysolutions.net/companies/oneblood-inc/79fab388-8638-45e8-9ea6-ca699ba36a75

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