# FDA 483 - Banco Vida Corp. - August 12, 2021

Source: https://www.keypedia.com/records/483/banco-vida-corp/fead2d6c-f4d7-4f85-b626-d362ab608582

> FDA 483 for Banco Vida Corp. on August 12, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Banco Vida Corp.
- Inspection Date: 2021-08-12
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: Banco Vida Corp. in San Juan, PR, was cited for failing to establish and maintain adequate procedures for screening and determining the eligibility of HCT/P donors. Specifically, the firm lacked standard operating procedures for screening blood relatives of umbilical cord blood tissue donors and did not include ZIKV risk factors in its donor screening for allogeneic umbilical cord blood tissue donors. This observation is a recurrence from a previous FDA inspection.

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## Related Officers

- [Laura E. Garcia](https://www.keypedia.com/people/laura-e-garcia/ad7c9bee-bbff-494f-b9cf-35c3a04316c0)
- [Annette Melendez](https://www.keypedia.com/people/annette-melendez/bc1a065d-6408-4c4b-9dcf-c6884e8a75c4)

Company: https://www.keypedia.com/companies/banco-vida-corp/6710f827-76c1-4157-8a90-93c6458c3eca

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-iv/a8c8fd15-4e7a-46cb-903a-9980f7ea89e6