# FDA 483 - CBR Systems Inc - June 03, 2009

Source: https://www.keypedia.com/records/483/cbr-systems-inc/becfc986-00e0-4470-a928-bc2e30a530ad

> FDA 483 for CBR Systems Inc on June 03, 2009. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: CBR Systems Inc
- Inspection Date: 2009-06-03
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: CBR Systems Inc, a cord blood/stem cell processor in Tucson, AZ, was cited for multiple deficiencies during an FDA inspection. Observations included inadequate processing to prevent contamination, unvalidated procedures for handling exposed products, insufficient donor screening for communicable diseases, and a lack of proper environmental monitoring for microorganisms.

## Related Documents

- [483 - 2012-06-14](https://www.keypedia.com/records/483/cbr-systems-inc/9d621feb-a11d-42f6-9de5-8abafe73f627)
- [483 - 2024-01-17](https://www.keypedia.com/records/483/cbr-systems-inc/558e5e66-c01d-4810-9dc3-c117c1f2a1a4)

## Related Officers

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

Company: https://www.keypedia.com/companies/cbr-systems-inc/da16fa2d-156f-4298-9b42-3b9d7758c374

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