# FDA 483 - HemaCare Corporation - November 28, 2007

Source: https://www.keypedia.com/records/483/hemacare-corporation/09ee4a32-b25b-4ef6-9527-a7af87b51c1c

> FDA 483 for HemaCare Corporation on November 28, 2007. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: HemaCare Corporation
- Inspection Date: 2007-11-28
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: HemaCare Corporation, a blood bank in Van Nuys, CA, was cited for multiple deficiencies related to donor record management, audit trails, and corrective actions during an FDA inspection from July to November 2007. Repeated observations highlighted issues with the Donor Deferral Registry's accuracy and incomplete corrective actions for biological product deviations. The inspection revealed systemic problems in data integrity, donor notification, and adherence to standard operating procedures.

## Related Officers

- [Tania Y. Hall](https://www.keypedia.com/people/tania-y-hall/94f342b2-a5f3-4ff1-ae5a-7f75fefe2214)

Company: https://www.keypedia.com/companies/hemacare-corporation/367cd64c-309c-40a6-b417-2e782ff6378f

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6