# FDA 483 - Charles River Laboratories Cell Solutions Inc - September 03, 2013

Source: https://www.globalkeysolutions.net/records/483/charles-river-laboratories-cell-solutions-inc/f4374349-685e-4ea1-b27f-086faeaf5402

> FDA 483 for Charles River Laboratories Cell Solutions Inc on September 03, 2013. 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: 2013-09-03
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Hemacare Corporation, a blood bank and donor center in Van Nuys, CA, received an FDA Form 483 for failing to perform thorough investigations of unexplained discrepancies. This included inadequate investigations into erroneously retested CMV positive donor units, leading to inappropriate labeling and shipping, and a failure to determine the root cause of a quarantined unit being labeled and shipped prematurely. These observations highlight significant concerns regarding the firm's quality control and product release processes.

## Related Documents

- [483 - 2009-09-10](https://www.globalkeysolutions.net/records/483/charles-river-laboratories-cell-solutions-inc/44f82b27-59e6-4d28-92f9-0152b50ddfcc)
- [483 - 2011-09-08](https://www.globalkeysolutions.net/records/483/charles-river-laboratories-cell-solutions-inc/45d5d372-2160-4a95-823b-9a1fe15e2fd1)

## 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