# FDA 483 - Banco Vida Corp. - September 18, 2019

Source: https://www.keypedia.com/records/483/banco-vida-corp/e1632579-f12c-43e0-9526-55c89ccc4ede

> FDA 483 for Banco Vida Corp. on September 18, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Banco Vida Corp.
- Inspection Date: 2019-09-18
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - East IV
- Summary: Banco Vida Corp. in San Juan, PR, received a Form 483 with four observations related to deficiencies in donor screening and testing for human cells, tissues, and cellular and tissue-based products (HCT/Ps). The firm failed to adequately screen donors for communicable disease risk factors, including ZIKV and Creutzfeldt-Jacob Disease (CJD), and lacked proper procedures for donor eligibility determination. Additionally, the firm used an uncleared test for syphilis screening.

## Related Documents

- [WARNING_LETTER - 2019-09-18](https://www.keypedia.com/records/warning_letter/banco-vida-corp/30f4c14d-0486-4d6d-a6c8-36966a0be22f)
- [WARNING_LETTER - 2019-09-18](https://www.keypedia.com/records/warning_letter/banco-vida-corp/a2bf2f67-4b2d-454a-9e88-0fa2e8413208)
- [483 - 2021-08-12](https://www.keypedia.com/records/483/banco-vida-corp/fead2d6c-f4d7-4f85-b626-d362ab608582)

## Related Officers

- [Annette Melendez](https://www.keypedia.com/people/annette-melendez/bc1a065d-6408-4c4b-9dcf-c6884e8a75c4)
- [Investigator](https://www.keypedia.com/people/irina-gaberman/c863b2de-4c64-40d2-a390-289d293e5a8f)

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