# FDA 483 - ABO Holdings Inc - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/abo-holdings-inc/88257aae-cc5b-4095-b7a0-68725eaaaced

> 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. in San Diego, California, a plasmapheresis center, was cited for two significant issues during an FDA inspection. The firm failed to correctly perform Performance Qualification studies for centrifuges used in donor qualification by selecting incorrect assay values. Additionally, the firm did not test subsequent donations for relevant transfusion transmitted infections (RTTI) when a donor previously tested reactive, leading to samples not being shipped to the contract testing laboratory.

## Related Officers

- [Carmelita F. Bibby](https://www.globalkeysolutions.net/people/carmelita-f-bibby/a6b5a902-9e12-4305-ac5c-e532331a1cdb)

Company: https://www.globalkeysolutions.net/companies/abo-holdings-inc/7e2bfd56-3eac-40d3-8db5-36b1f52657cd

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