# FDA 483 - ABO Holdings Inc - Unknown Date

Source: https://www.keypedia.com/records/483/abo-holdings-inc/612c3b3e-533b-45f6-b108-0dd015bd9913

> 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: Office of Medical Device and Radiological Health Operations
- Summary: ABO Holdings, Inc., a plasmapheresis center in San Diego, California, was cited for two significant observations during an FDA inspection. The firm failed to correctly perform Performance Qualification studies for centrifuges by using incorrect assay values. Additionally, the firm did not test subsequent donations from donors who previously tested reactive for relevant transfusion transmitted infections (RTTI).

## Related Documents

- [483 - Unknown Date](https://www.keypedia.com/records/483/abo-holdings-inc/88257aae-cc5b-4095-b7a0-68725eaaaced)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4