# FDA 483 - American Blood Bank Corp. - August 07, 2019

Source: https://www.globalkeysolutions.net/records/483/american-blood-bank-corp/a609a81c-e31f-4645-b7c1-82a111f512b0

> FDA 483 for American Blood Bank Corp. on August 07, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: American Blood Bank Corp.
- Inspection Date: 2019-08-07
- Product Type: biologics
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: American Blood Bank Corp. in Miami, FL, a blood bank establishment, was cited for significant deficiencies during an FDA inspection. Observations included failures in donor suitability determination due to pre-populated questionnaires and skipped screening questions, as well as the release of unsuitable blood components (HIV and HCV positive) that were still under quarantine. Additionally, the firm used expired antiseptic solutions for phlebotomy site preparation and failed to obtain required donor contact information.

## Related Officers

- [Fabian N. Chaparro-rodriguez](https://www.globalkeysolutions.net/people/fabian-n-chaparro-rodriguez/f14fd931-0830-4a84-a287-2dd85e40195d)
- [Annette Melendez](https://www.globalkeysolutions.net/people/annette-melendez/bc1a065d-6408-4c4b-9dcf-c6884e8a75c4)

Company: https://www.globalkeysolutions.net/companies/american-blood-bank-corp/71dd8d8c-0a55-4cf9-a5df-acdb245bf4e8

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6