# FDA 483 - ABO Holdings Inc - Unknown Date

Source: https://www.keypedia.com/records/483/abo-holdings-inc/fe1cc420-4716-4522-a7a0-f4113e273a00

> FDA 483 for ABO Holdings Inc on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ABO Holdings Inc
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: ABO Holdings, Inc., a plasmapheresis center in Calexico, California, was cited for failing to provide essential information to donors deferred due to reactive screening test results for Relevant Transfusion-Transmitted Infections (RTTI). This includes not informing donors about their deferral status, the types of donations they should no longer make, and the specific RTTI test results that led to their deferral. This lapse in donor notification is a significant compliance issue impacting donor safety and public health.

## Related Officers

- [Christi Ann L. Samella](https://www.keypedia.com/people/christi-ann-l-samella/71bfa6f5-fa6c-48b9-866d-3ae61565eb2e)

Company: https://www.keypedia.com/companies/abo-holdings-inc/9e2697ca-b89c-445c-842a-756dda3bb91a

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd