# FDA 483 - Charles River Laboratories Cell Solutions Inc - September 10, 2009

Source: https://www.globalkeysolutions.net/records/483/charles-river-laboratories-cell-solutions-inc/44f82b27-59e6-4d28-92f9-0152b50ddfcc

> FDA 483 for Charles River Laboratories Cell Solutions Inc on September 10, 2009. 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: 2009-09-10
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: HemaCare Corporation in Van Nuys, CA, was cited for significant deficiencies in its electronic equipment checking, record-keeping, and standard operating procedures related to donor management. The inspection revealed issues with the computer system's ability to prevent and identify duplicate donor records, a lack of documentation for critical override decisions, and incomplete procedures for resolving potential duplicate donors and communicating deferrals. These findings indicate a moderate level of severity concerning data integrity and procedural control in donor screening.

## Related Documents

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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