# FDA 483 - Charles River Laboratories Cell Solutions Inc - September 08, 2011

Source: https://www.globalkeysolutions.net/records/483/charles-river-laboratories-cell-solutions-inc/45d5d372-2160-4a95-823b-9a1fe15e2fd1

> FDA 483 for Charles River Laboratories Cell Solutions Inc on September 08, 2011. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Charles River Laboratories Cell Solutions Inc
- Inspection Date: 2011-09-08
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Hemacare Corporation, a blood bank in Van Nuys, CA, was cited for significant deficiencies during an FDA inspection. Observations included failures to thoroughly investigate product failures, leading to the distribution of quarantined blood components and inappropriate resolution of duplicate donor records. Additionally, the firm's standard operating procedures lacked adequate descriptions for donor notification and follow-up processes.

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## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/charles-river-laboratories-cell-solutions-inc/7fb17fcc-f9f6-4c4b-9f9c-ea65e724f40e

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