# FDA 483 - California Cryobank, Inc - August 07, 2009

Source: https://www.globalkeysolutions.net/records/483/california-cryobank-inc/982851ec-e98e-4162-ba51-e7117253c3df

> FDA 483 for California Cryobank, Inc on August 07, 2009. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: California Cryobank, Inc
- Inspection Date: 2009-08-07
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of California Cryobank, Inc. in Los Angeles, CA, a cord blood/stem cell processor, revealed significant deficiencies across multiple areas. The firm failed to validate critical processing procedures, ensure sterility of reagents, maintain an effective quality program, and adequately monitor environmental conditions. Additionally, issues were noted in donor eligibility screening and equipment cleaning protocols.

## Related Officers

- [Gene D. Arcy](https://www.globalkeysolutions.net/people/gene-d-arcy/a2def947-65fb-4056-84e2-1f89cf944cf0)

Company: https://www.globalkeysolutions.net/companies/california-cryobank-inc/e4186887-addc-4672-a943-b820f6159561

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