# FDA 483 - CBR Systems Inc - January 17, 2024

Source: https://www.keypedia.com/records/483/cbr-systems-inc/558e5e66-c01d-4810-9dc3-c117c1f2a1a4

> FDA 483 for CBR Systems Inc on January 17, 2024. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: CBR Systems Inc
- Inspection Date: 2024-01-17
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: CBR Systems Inc, a cord blood bank in Tucson, AZ, was cited for multiple deficiencies during an FDA inspection. Observations included using unverified and potentially contaminated supplies, inadequate environmental controls leading to microbial contamination, failure to maintain proper shipping conditions for HCT/Ps, inaccurate labeling, and unapproved computer software validation. These issues indicate significant concerns regarding product quality, safety, and compliance with regulatory requirements.

## Related Documents

- [483 - 2009-06-03](https://www.keypedia.com/records/483/cbr-systems-inc/becfc986-00e0-4470-a928-bc2e30a530ad)
- [483 - 2012-06-14](https://www.keypedia.com/records/483/cbr-systems-inc/9d621feb-a11d-42f6-9de5-8abafe73f627)

## Related Officers

- [Emily S. McGann](https://www.keypedia.com/people/emily-s-mcgann/43891ff3-bd70-4337-b61c-e16cc7ad0468)
- [Richard L. Bartlett](https://www.keypedia.com/people/richard-l-bartlett/602337b9-ac77-41bb-a254-71a9d345335b)
- [Garrad R. Poole](https://www.keypedia.com/people/garrad-r-poole/7fc97953-367e-459b-905d-25efe6ec39d2)

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